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This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009 Women living in Besançon or one of the 15 communes of the Dijon conurbation Who gave birth at Dijon or Besançon CHU Between 1st January 2005 and 31st December 2009 Criterion for the of cases Onset of a hypertension disorder during pregnancy defined according to expert recommendations Criterion for the of controls No hypertension disorder during pregnancy Medical termination of pregnancy Opposition to the use of their data | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 14.0-65.0, B-cell Acute Lymphoblastic Leukemia B-cell Lymphoma Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed 2. In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology 3. In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations: 1. Getting through 2 treatments of standard chemotherapy with CR not yet obtained 2. Reach CR for the first inducement, but CR lasts for ≦12 months 3. r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment 4. ≧2 times of recurrence 4. Remedial chemotherapy is not used within 4 weeks before cell therapy 5. Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy 6. Antibody drug treatment is not received within 2 weeks before cell therapy 7. Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia 8. No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92% 9. No contraindications for leukapheresis 10. Expected survival >3 months 11. Grade 0 or 1 of ECOG performance status Pregnant and breastfeeding women 2. Uncontrolled active infection 3. Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E. 4. Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks 5. Stage II-IV Acute/chronic general graft versus host disease 6. Gene therapy has been undergone in the past | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma Relapsed Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma DLBCL Male or female, aged ≥18 years. 2. Willing and able to give written, informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1. 4. Histologically confirmed DLBCL and large B cell lymphoma (at last relapse) subsets, including: Phase I and Phase II Cohort 1: 1. DLBCL, not otherwise specified (NOS), per World Health Organisation classification and DLBCL with MYC and BCL2 and/or BCL6 rearrangements (double/triple hit). 2. Transformed DLBCL from FL. 3. High-grade B cell lymphoma with MYC expression (excluding Burkitt's lymphoma) Phase I and Phase II Cohort 2: 4. Transformed DLBCL from other indolent lymphomas (excluding Richter's transformation). 5. Primary mediastinal large B cell lymphoma. 5. Chemotherapy-refractory disease, defined as one or more of the following: 1. Stable disease (≤12 months) or progressive disease as best response to most recent chemotherapy containing regimen. Refractory disease after frontline chemo-immunotherapy is allowed. 2. Disease progression or recurrence in ≤12 months of prior autologous haematopoietic stem cells transplantation (ASCT). OR 6. Relapse after ≥two lines of therapy or after ASCT. At a minimum: 1. Patients must have received rituximab or another anti-CD20 monoclonal antibody (unless Investigator determines that tumour is CD20-negative) and an anthracycline-containing chemotherapy regimen. 2. Patients must have either failed ASCT, or be ineligible for or not consenting to ASCT. 3. Patients with transformed DLBCL must have received at least one line of therapy after transformation to DLBCL. 7. PET-positive disease per Lugano classification. 8. For females of childbearing potential, a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment. For females who are not postmenopausal or surgically sterile, highly effective methods of contraception must be used during the treatment period and for at least 12 months after the last dose of study treatment. 9. For males, it must be agreed that that two acceptable methods of contraception are used. 10. Adequate renal, hepatic, pulmonary, and cardiac function defined as: 1. Creatinine clearance ≥40 cc/min. 2. Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x ULN. 3. Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome. 4. LVEF ≥50% (by ECHO or MUGA) unless the institutional lower limit of normal is lower. 5. Baseline oxygen saturation >92% on room air and ≤Grade 1 dyspnoea. 11. Patient has adequate BM function without requiring ongoing blood product or granulocyte-colony stimulating factor support and meets the following 1. Absolute neutrophil count ≥1.0 × 109/L. 2. Absolute lymphocyte count ≥0.3 × 109/L (at enrolment and prior to leukapheresis). 3. Haemoglobin ≥80 g/L. 4. Platelets ≥75 × 109/L 12. No contra-indications for leukapheresis Prior allogeneic haematopoietic stem cell transplant. 2. Females who are pregnant or lactating. 3. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis. 4. Patients with active CNS involvement by malignancy. Patients with history of CNS involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to AUTO3 infusion). 5. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event. 1. Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded). 2. Evidence of pericardial effusion 6. Patients with a history (within 3 months) or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning. 7. Patients with active gastrointestinal bleeding. 8. Patients with any major surgical intervention in the last 3 months. 9. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis. 10. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months. 11. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS. 12. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis. 13. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed). 14. Prior treatment with PD1, PD-L1, or cytotoxic T lymphocyte-associated protein-4-targeted therapy, or tumour necrosis factor (TNF) receptor superfamily agonists within 6 weeks prior to AUTO3 infusion. 15. Prior treatment with investigational or approved gene therapy or cell therapy products until a dose level has treated at least three patients and has been declared safe. 16. Prior CD19 or CD22 targeted therapy. 17. The following medications are excluded: 1. Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to AUTO3 administration. However, physiological replacement, topical, and inhaled steroids are permitted. 2. Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or AUTO3 infusion. 3. Cytotoxic chemotherapies within 2 weeks of AUTO3 infusion and 1 week prior to leukapheresis (2 weeks for lymphodepleting chemotherapy). 4. Antibody therapy use including anti-CD20 therapy within 2 weeks prior to AUTO3 infusion, or 5 half-lives of the respective antibody, whichever is shorter. 5. Granulocyte-colony stimulating factor less than 10 days prior to leukapheresis. 6. Live vaccine ≤4 weeks prior to enrolment. 7. Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy. 18. Prior limited radiation therapy within 4 weeks of AUTO3 infusion or within 24 weeks for definitive radiation to chest. 19. Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. 20. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine, pembrolizumab or tocilizumab. 21. Any contraindications to receive anti-PD1 antibody pembrolizumab will be excluded from cohorts requiring administration of pembrolizumab. 22. Patients, who in the opinion of the Investigator, may not be able to understand or comply with the safety monitoring requirements of the study. 23. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial. Phase I outpatient cohort: 24. Subjects who do not have caregiver support (in line with institutional outpatient transplant guidelines) for outpatient/ambulatory care setting. 25. Subjects who are staying greater than 60 minutes (or whatever is permissible per institutional outpatient transplant guidelines) from the clinical trial site at the time of treatment. For AUTO3 Infusion: Patients meeting any of the following must not be treated with AUTO3 or have treatment delayed until they no longer meet these 1. Severe intercurrent infection. 2. Requirement for supplementary oxygen or active pulmonary infiltrates. 3. Clinical deterioration of organ function (renal and hepatic) exceeding the set at study entry | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-64.0, Lymphoma, Large B-Cell, Diffuse Age 18 years Histologically confirmed CD20+ DLBCL based on revised WHO 2008 Lymphoma Classification. The following subgroups and variants can be included ALK-positive large B-cell lymphoma Intravascular large B-cell lymphoma T-cell rich B-cell lymphoma Myc/BCL-2 double hit lymphoma Follicular lymphomas grade 3b DLBCL with previously undiagnosed concurrent small cell infiltration in bone marrow, lymph node, or extranodal site and lymphomas intermediate between DLBCL and Burkitt's lymphoma are allowed Posttransplantation lymphoma (PTLD), discordant or transformed lymphoma are NOT allowed Severe cardiac disease: cardiac function grade 3-4, left ventricular ejection fraction <45% Impaired bone marrow liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule (Hemoglobin < 9 g/dL, ANC < 1.5 × 109/L, Platelet count < 75 × 109/L, creatinine clearance < 40 mL/min, ALT/AST > 2.5 x ULN, bilirubin 1.5 x ULN, INR > 1.5) Pregnancy/lactation Men and women of reproductive potential not agreeing to use effective contraception during treatment and for 18 months after completion of treatment (Effective contraception is combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), hormone-releasing IUD, bilateral tubal occlusion, vasectomised partner, or sexual abstinence Patients with other severe medical problems, including active infections, cardiac or pulmonary disease, history of PML and with an expected short survival for non-lymphoma reasons Known HIV positivity Active or chronic hepatitis B virus (HBV) infection (defined as positive HBsAg serology), or active hepatitis C virus (HCV) infection (defined by antibody serology testing). HBsAg, HBcAb, and HCVAb must be tested during screening. Patients who have protective titers of HBsAb along negative HBsAg after vaccination or prior but cured hepatitis B are eligible Vaccination with a live vaccine within one month prior to randomization Patients with a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment Earlier treatment containing anthracyclines | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma The disease was diagnosed by Hodgkin's or non Hodgkin's lymphoma years of age or older at diagnosis The diagnosis was confirmed within 6 months before admission Informed consent was obtained There are no special in this study | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Mantle-Cell Lymphoma Relapsed or refractory, pathologically proven mantle cell lymphoma. Must have a current or prior tissue sample that is IHC positive for cyclin D 1 or that is positive by FISH or cytogenetics for t(11;14) Must have been refractory to and/or relapsed/progressed after at least 1 prior therapy Prior autologous or allogeneic transplant are allowed. Patients may not have active grade II-IV acute graft-versus-host disease (GVHD) or moderate/severe chronic GVHD by NIH and may not require immunosuppressive medications and/or corticosteroids for the management of acute or chronic GVHD Phase I: Prior proteasome inhibitor and/or Bruton's tyrosine kinase (BTK) inhibitors are allowed but patients may not have been exposed to the combination of proteasome inhibitor and BTK inhibitor. Patients who have progressed on ibrutinib that are felt to be at high risk for rapid progression on this study shall not be eligible for the phase I portion of the study. NOTE: Ibrutinib pre-treated patients must meet all AND must have discontinued prior ibrutinib at least 3 months prior to starting study therapy. PHASE I 25, 2019 Phase II: Prior proteasome inhibitors allowed. (Please note prior to Version 3.0 of the protocol prior proteasome inhibitor and/or Bruton's tyrosine kinase inhibitors were allowed but patients could not have been exposed to the combination of proteasome inhibitor and BTK inhibitor) Age ≥ 18 years Eastern Oncology Oncology Group (ECOG) performance status of 0-2 Ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent Willing to provide archived tumor tissue, bone marrow (if sufficient bone marrow and tumor tissue are available) and blood samples for research Adequate organ function as measured by the following | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-55.0, Insulin Sensitivity Endothelial Dysfunction Blood Pressure Male and female 55 years of age BMI 25-40 No recent history of starting a structured exercise program or diet in the last 3 months Current smoker and/or recreational drug user Answers "yes" to one or more questions on the Physical Activity Readiness Questionnaire Diagnosed diabetes, heart disease History of anabolic steroid use in the past six months Taking medications for treatment of diabetes, heart disease, and hypertension Orthopedic or musculoskeletal contraindications to resistance training Unwilling to follow any aspect of the study protocol including blood sampling and weight training | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 30.0-85.0, Cardiovascular Disease Cardiovascular disease patients (30-85 years old) who have been living in Guangdong province for more than 5 years Patients have been diagnosed with primary hypertension, coronary heart disease, heart failure or peripheral vascular disease, etc Patients with cardiogenic (acute pericarditis, rheumatic coronary arteritis, hypertrophic cardiomyopathy, etc.) Or non-cardiogenic chest pain any subject who suffer from malignant tumors, infectious diseases, advanced liver disease, major disability and cannot participate in the study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Embolic Stroke of Undetermined Source Ischemic Stroke Atrial Fibrillation and Flutter Myocardial Infarction Cardiac Tumor Endocarditis Patent Foramen Ovale stroke of undetermined cause unstable hypertension atrial fibrillation hyperthyroidism hard pregnancy and breastfeeding dialysis cancer autoimmunologic disease active infection incapable of giving agreement | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphomas Non-Hodgkin's B-Cell Patients with relapsed/refractory CD19+ Non-Hodgkin's lymphoma of the following subtypes Diffuse large B-cell lymphoma (DLBCL) Mantle cell lymphoma (MCL) Follicular lymphoma (FL) Chronic lymphocytic leukemia and Small lymphocytic lymphoma (CLL/SLL) Burkitt's Lymphoma Ability to provide written informed consent for the protocol Willingness and ability to comply with scheduled visit, treatment plans, laboratory tests, and other procedures Age ≥ 18 years old Eastern Cooperative Oncology Group performance status of ≤ 2 Prior Treatment: 1. With any prior anti-CD19/anti-CD19 CAR-T or cellular therapy (prior Blinotumomab therapy is allowed) 2. Treatment with any prior gene therapy 3. Prior allogeneic hematopoietic stem cell transplant 4. Received chemotherapy, radiation or surgical resection of malignancy within 2 weeks prior to the start of conditioning chemotherapy (day -10 to -5) Active, uncontrolled serious infection or medical or psychiatric illness, that in the investigator's opinion is likely to interfere with participation in this clinical trial Active CNS involvement by malignancy History of seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement Active replication of hepatitis B or active hepatitis C (HCV RNA positive). Those with prior disease who are PCR negative at enrollment and meet liver function criterion are eligible Known HIV positive patients Patients with unstable angina and/or myocardial infarction within 6 months prior to screening Cardiac arrhythmia not controlled with medical management, evidence of pericardial effusion on imaging that is compromising function Previous or concurrent malignancy with exception of adequately treated basal cell or squamous cell carcinoma, in-situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to study drug infusion, or prostate cancer that was treated with prostatectomy or radiotherapy over 2 years before day 1 of protocol therapy and patients whose PSA is undetectable at study entry Autoimmune disease or history of primary immunodeficiency (excluding Hashimoto's thyroiditis, vitiligo, or DM type I) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 40.0-85.0, Acute Myocardial Infarction, of Inferolateral Wall Acute Myocardial Infarction, of Inferoposterior Wall first attacked acute inferior MI patients those with 1). previous AMI, 2). coronary artery bypass surgery, 3). electrocardiographic evidence of bundle branch block, 4). undetermined culprit site by coronary angiography, 5) first electrocardiogram obtained more than 12 hours after the onset of symptoms | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Key 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) DLBCL not otherwise specified (ABC/GCB) HGBL with or without MYC and BCL2 and/or BCL6 rearrangement DLBCL arising from FL T-cell/histiocyte rich large B-cell lymphoma DLBCL associated with chronic inflammation Primary cutaneous DLBCL, leg type Epstein-Barr virus (EBV) + DLBCL 2. Relapsed or refractory disease after first-line chemoimmunotherapy Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded Progressive disease (PD) as best response to first-line therapy History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years 2. Received more than one line of therapy for DLBCL 3. History of autologous or allogeneic stem cell transplant 4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. 5. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing. 6. Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. 7. History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement 8. Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted. 9. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7 Note: Other protocol defined Inclusion/ | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-60.0, Therapy Related Leukemia Relapsed/Refractory B-ALL patients 2. Did not achieve complete remission after 2 times of standard plan chemotherapy 3. Relapsed after first induction chemotherapy 4. Did not response to chemotherapy before HSCT or relapsed after HSCT 5. Cannot receive allo-HSCT or refuse to receive allo-HSCT 6. Relapsed after CD19-CART infusion 7. MRD monitoring confirmed positive(MRD>0.01%) after CD19-CART infusion 8. Cell phenotype is CD19 negative and CD20/CD22/CD10 positive (single or combined) after CD19-CART therapy 9. Estimated survival time is more than 3 months in leukemia 10. Volunteered for this clinical trail and signed a consent form MRD was negative after CD19-CART therapy 2. MRD was negative while the cell phenotype was CD19 expressed 3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions 4. Patients with severe mental illness, neurological disease or infectious disease 5. Patients with GVHD was taking immunosuppressants 6. Pregnant or lactating women 7. Patients have received other genetic therapy products 8. Transfection efficiency was less than 30% 9. Any situation may do harm to the subjects or interfere the results | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 40.0-90.0, Osteo Arthritis Knee Primary osteoarthritis of the knee scheduled for knee replacement surgery Must be able to perform physical exercise Age 40-90 years old BMI 18.5-40 kg/m^2 None smoker for the last 6 weeks Regular intake of non steroid anti-inflammatory drugs (NSAID) corticoid-steroids disease modifying anti-rheumatic drugs (DMARD) cytostatic incl. chemotherapy immune suppressive medicine Inflammatory diseases or cancer Recent trauma to the knee (< 3 months) Previous knee surgery Regular strenuous exercise ( > 1 pr. month) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 20.0-40.0, Polycystic Ovary Syndrome (PCOS) Metabolic Syndrome Malay women aged 20-40 years of age clinically healthy and euthyroid (clinically and biochemically) and not on any medication women on any hormonal medications | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Central Nervous System Infections Bacterial Meningitis Viral Meningitis Aseptic Meningitis Encephalitis Brain Abscess Neuroborreliosis Neurosyphilis Lyme Disease Tertiary Syphilis Cerebral Abscess Meningitis Definitions of central nervous system infections: For all cases with unproven aetiologies no alternative diagnosis than CNS infection is thought more likely after completed multidisciplinary diagnostic work-up. Viral meningitis All patients have to have a clinical presentation consistent with non-bacterial meningitis (e.g. headache, neck stiffness, photo or phonophobia, fever) and Cerebrospinal fluid leukocytes>10 cells/ml Patients with viral meningitis with undetermined pathogen have to have CSF leukocytes> 10/mL and no other more probable diagnosis assessed by the local investigator. In case of doubt, patients are discussed with the secretary and chair or at meetings. Bacterial meningitis All patients have to have a clinical presentation consistent with bacterial meningitis (e.g. headache, neck stiffness, fever, altered mental status) and Proven bacterial aetiology (CSF or blood culture/DNA based technology or antigen tests) Patients with bacterial meningitis in whom the bacteria cannot not be cultured or identified by DNA-based technologies have to have CSF leukocytes> 10/mL and no other more probable diagnosis assessed by the local investigator. In case of doubt, patients are discussed with the secretary and chair or at meetings. Encephalitis All patients have to have a clinical presentation consistent with encephalitis (e.g. headache, fever, focal neurological deficit, altered mental status >24 hours) as defined by the International Encephalitis Consortium (Venkatesan A et al., Clin Infect Dis 2013; doi:10.1093/cid/cit458.). Encephalitis We cases of proven or suspected autoimmune encephalitis. Primary brain abscess All patient have a clinical presentation consistent with brain abscess (e.g. headache, focal neurological deficit, mass lesion on cranial imaging) and Proven microbiological aetiology by culture/DNA-based technology from pus from brain abscess or blood or CSF or Aspiration of pus from the brain abscess or Response to antimicrobial treatment or Tumour ruled out or Tumour thought less probable than abscess on MRI using diffusion weighted imaging (DWI) and apparent diffusion coefficient (ADC) sequences. Lyme neuroborreliosis A clinical presentation consistent with neuroborreliosis (e.g. radiculopathy) and CSF pleocytosis>10 leukocytes/mL and Positive intrathecal B.burgdorferi antibody production index. Neurosyphilis | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Shoulder Pain Bone Mineral Density Muscle Strength Selected to undergo a unilateral bicep tenodesis Males and females age 18-65 DoD beneficiaries Must be able to read and write in English in order to consent Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10 Rehabilitation protocol with prohibited muscle strengthening greater than 6 weeks post-operation Current metallic implants that contraindicate or significantly affect the sensitivity of DEXA scan Current implanted defibrillator or pacemaker Pregnancy per patient self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in this study Recent history of deep vein thrombosis within the 12 months or on active treatment with anticoagulants Currently taking medications that are known to affect bone density to heparin, warfarin, glucocorticoids, medroxyprogesterone acetate, cancer treatment medications, bisphosphonates or other osteoporosis treatment medications, and thyroid hormone History of hyperparathyroidism History of upper quadrant lymph node dissection | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Non-inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Male and female ≥18 years Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement Rheumatoid arthritis Correction of functional deformity Voluntary written Informed Consent obtained Pre-operative Prospect for recovery to independent mobility compromised by known coexistent medical problems Requiring revision hip replacement Requiring bilateral hip replacement Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points Likely post-operative leg length inequality >5cm Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity) Primary or metastatic tumour involving this hip Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint Previous organ transplant | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Cholecystitis, Acute Acute cholecystitis according to the Tokyo Guidelines 2013 Difficulties to communicate | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma, Non-Hodgkin Subjects must satisfy the following to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF) 2. Subject must understand and voluntarily sign an ICF prior to any study-related ssessments/procedures being conducted 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements 4. Investigator considers the subject is appropriate for adoptive T cell therapy 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Subjects not eligible for transplant (TNE) in Cohorts 2 and 3 and subjects in Cohort 5 may be enrolled with ECOG of 2 only if they meet all other inclusion/ 6. Subjects with one of the following: Cohort 1: Subjects with DLBCL NOS (de novo or tFL), HGBL and FL3B per WHO 2016 classification (Swerdlow, 2016), after ≥ 2 lines of therapy*, including an anthracycline and rituximab (or other CD20-targeted agent) Cohort 2: Transplant not eligible subjects with DLBCL NOS (de novo or tFL), HGBL and FL3B per WHO 2016 classification (Swerdlow, 2016), who failed first line therapy*, including an anthracycline and rituximab (or other CD20-targeted agent) Transplant not eligible subjects will those who are deemed ineligible for high-dose chemotherapy and HSCT due to age, performance status or comorbidity, while also having adequate organ function for CAR T cell treatment. At the very least, subjects have to meet one of the following 1. Age ≥ 70 years 2. ECOG performance status ≥ 2 3. Impaired pulmonary function (DLCO ≤ 60%, adjusted for hemoglobin concentration using the Dinakara equation) 4. Impaired cardiac function (LVEF < 50%) 5. Impaired renal function (CrCl < 60 mL/min) 6. Impaired hepatic function (AST/ALT > 2 x ULN, bilirubin ≥ 2 mg/dL or cirrhosis Child-Pugh B or C) Subjects must fulfil all other in and Cohort 3 (Japan only): Subjects meeting for either Cohort 1 or 2 Cohort 4: Subjects with newly diagnosed HGBL. Subjects must be eligible for anthracycline and rituximab (or other CD20-targeted agent) containing regimen as induction prior to consolidation with JCAR017** Cohort 5: Subjects with PCNSL who failed first line therapy with HDCT and ASCT Cohort 6: (REMOVED) Cohort 7: Subjects meeting for Cohort 1 and suitable for outpatient treatment*** For subjects with transformed disease, the subject should have had at least 2 lines of systemic therapy for his/her transformed disease (ie, DLBCL) for Cohort 1 and 1 line for Cohort 2 to be eligible. Lines of therapy do not those given for a previously indolent condition (ie, follicular lymphoma). Subjects do NOT have to have anthracycline for their DLBCL if received for indolent disease For subjects already undergoing anthracycline and rituximab containing regimen, is to be discussed with Medical Monitor. Subjects with complete metabolic response after 2 cycles of induction will proceed with JCAR017 infusion only at time of relapse, if applicable Subjects must meet the conditions for outpatient treatment and monitoring as outlined in the Outpatient Administration and Monitoring Guidance for Lisocabtagene Maraleucel. Note: Subjects with secondary CNS lymphoma involvement may enroll in Cohorts 1 to 4 and 7; subjects with PCNSL are eligible for Cohort 5. Subject selection must consider clinical risk factors for severe adverse events (AEs) and alternative treatment options. Subjects should only be enrolled if the Investigator considers the potential benefit outweighs the risk for the subject. For Cohort 5 and to not compromise safety, subject selection has been restricted to those fit enough to HDCT and ASCT as their prior therapy. 7. Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated. Note: If the subject did not experience CR since last biopsy, the most recent biopsy will be considered adequate to participate in the trial. For subjects with PCNSL, at a minimum, corresponding pathology report is required if archival tumor material is not available and repeated biopsy not feasible. 8. (REMOVED) For subjects with NHL and Richter's transformed CLL 9. For subjects with PCNSL: Subjects must have disease that is objectively measurable by International Workshop to Standardize Baseline Evaluation and Response in Primary Central Nervous System (CNS) Lymphoma (Abrey, 2005), cerebrospinal fluid (CSF) cytology (in case of leptomeningeal only disease), or vitreal aspiration cytology and/or retinal photographs (in case of ocular lymphoma if clinically indicated) 10. Adequate organ function, defined as Adequate bone marrow function to receive LD chemotherapy as assessed by the Investigator Serum creatinine < 1.5 x ULN or creatinine clearance > 30 mL/min (estimated glomerular filtration rate [eGFR] by Cockroft Gault) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, Diffuse Large B-cell Lymphoma previously untreated. CD20 Positive DLBCL. 2. Lymphoma International PrognosisIndex (IPI) score of 0-3, stage I-IV. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, Expected survival>6 months. 4. At least 1 bi-dimensionally measurable lesion: Nodal lesion: Greatest transverse diameter ≥1.5cm and short axis ≥1.0cm; Extra-nodal lesion: Greatest transverse diameter≥1.0cm. 5. CBC: WBC >4 x 10^9/L;NEU > 2 x 10^9 / L; PLT > 100 x 10^9 / L; Patients with bone marrow infiltration: WBC≥3 x 10^9/L、HGB≥80g/L、NEU≥1.5 x 10^9/L、PLT≥75 x 10^9/L； 6. hepatic function: TBIL≤1.5 x ULN；ALT or AST ≤2.5 x ULN； ALP≤3 x ULN if with no bone marrow infiltration;Renal function: Cr≤1.5 x ULN； 7. HIV negative; 8. HCV-Ab negative OR HCV-Ab positive but HCV-RNA negative. 9. HBsAg and HBcAb negative,HBsAg or HBcAb positive with HBV DNA<1×1000IU / ml. 10. Cardiac echocardiography :LVEF ≥ 50%; 11. Must agree to take effective birth control methods or are not of childbearing potential. Women must agree to continue contraceptive measures within 12 months after the last treatment. Men must agree to continue contraception within 3 months after the treatment. 12. All patients must have signed an informed consent document Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system or B-cell lymphomas, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma, orB-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma, or primary mediastinal thymic large B-cell lymphomas or primary effusion lymphoma or plasmablastic lymphoma or primary cutaneous DLBCL,leg type or ALK+large B-cell lymphoma or transformed lymphoma or primary testicular DLBCL. 2. Confirmed DLBCL with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH. BCL-2 ≥ 70% positive and c-MYC ≥ 40% positive and according to Han's immunohistochemistry method, tumor type is GCB but unable to get unequivocal FISH result. 3．History of other cancers( excluding squamous cell carcinoma of skin, basal cell carcinoma of skin, carcinoma in situ of cervix) within 5 years prior to the enrollment of the study. 4.Patients who received major surgeries (excluding diagnostic surgeries) within 2 months prior to the enrollment of the study. 5. Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy); 6.Patients who received cytotoxic drugs or anti-CD20 monoclonal antibody for other diseases (such as Rheumatoid arthritis). 7. Patients who received any monoclonal antibody within 3 months prior to the enrollment of the study. 8. Patients who participated in other clinical trials within 3 months prior to the enrollment of the study. 9. Patients who received attenuated or live virus vaccine within 1 months prior to the enrollment of the study. 10. Patients who received hematopoietic stimulating factors within 2 weeks prior to the enrollment of the study. 11. Patients who received prednisone>30 mg per day or equivalent corticosteroids for controlling the symptoms other than lymphoma; Patients who received prednisone≤30 mg per day or equivalent corticosteroids should receive stable dose for at least 4 weeks before randomization by written record. 13. Patients with peripheral nervous system or central nervous system disease. 14. Suspected active or latent tuberculosis infections. 15. Within 4 months prior to the enrollment of the study, Patients had active bacteria, virus, fungi, mycobacteria,parasites or other infections(excluding nail bed fungal infection) or in need of intravenous antibiotic treatment or with sever systemic infection or in need of inpatient admission hospital(except for the treatment of neoplastic fever). 16. Other serious diseases that may impair the ability of subjects' participation(e.g., uncontrollable diabetes, (severe cardiac dysfunction, history of myocardial infarction or unstable arrhythmias or unstable angina within the past 6 months or gastric ulcer (gastric ulcer with risk of perforation) or active autoimmune disease or severe hypertension, etc.). 17. Contraindicative to any drug in CHOP, or to anthracycline;Patients with diabetes and intolerant to the prednisone in this study. 18. History of alcohol abuse or drug abuse. 19. Susceptible to allergies or allergic to anyactive ingredients or excipients in the trial (including CHOP) or murine source products ormedication (including CHOP) including active ingredients or excipients or rat source products or heterogeneous proteins. 20. Patients with serious mental disease. 21. Patients who are lack of compliance during the trial and/or the follow-up phase. 22. Patients that researchers deem as not appropriate to enter the study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-60.0, High Risk Pregnancy Multidisciplinary Communication Communication Obstetric Complication Records of all female, obstetric patients of child-bearing age who were evaluated in the Center for Peripartum Optimization during the period between January 2017 and January 2018 Controlled group will parturients with match high risk comorbidities or history of nonobstetric surgery during pregnancy who delivered at Johns Hopkins Hospital (JHH) during July 1, 2016 Dec 31, 2016 Patients with any one or more of these high risk comorbidities Complex spine pathologies (Scoliosis, vertebral fusion, disc disease, spinal canal defects, neuropathies, and nerve disease, etc.) Neurological pathology (Cerebral ischemia, tumor, increased intracranial pressure, cerebral vascular disease, etc.) Cardiac disease (Congenital, valvular, pulmonary hypertension, cardiomyopathy, ischemic disease, arrhythmia, etc.) Pulmonary disease (History of pulmonary embolism, interstitial lung disease, severe asthma, cancer, etc.) Morbid Obesity (Obstructive Sleep Apnea, equipment considerations) Hematologic Disorders (Thrombophilias, coagulopathies, patients on anticoagulation) Records of CPO participating parturients outside the specified timeframe Records of obstetric patients of child-bearing age without high-risk comorbid conditions described in criteria Records of patients seen in CPO clinic that did not deliver at our institution | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Bone Loss, Alveolar Dental Implant Failure Nos Any healthy patient scheduled for an implant-supported restoration will be considered for in this study, independently of the implant and prosthetic protocols used general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV) patients <18 years of age smoking habit (>10 cigarettes/day) sites with acute infection or requiring regenerative procedures Full Mouth Plaque Score Full Mouth Bleeding Score >25 % pregnant and lactating | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study. 2. Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation. 3. Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy Current or previous (within the last two years) indeterminate or not classified colitis. 2. Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years. 3. Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial. 4. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 5. Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 6.0-12.0, Malignant Haemopathy Children from 6 to 12 years old Brother or sister of a child: O has malignant haemopathy O follow-up in the pediatric hematology department in Lille, O diagnosed from 6 weeks to 1 year before maintenance of the healthy subject included whose parents are able to understand and sign voluntarily informed consent Affiliated to a social security scheme Ability to understand and answer questions alone during the semi-structured interview Child under 6 years or over 12 years Subject with a pathology that may interfere with the course of the study, according to the investigator's assessment Absence of the informed consent of one of the parents and / or the legal representative Refusal of participation of the subject | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 40.0-75.0, Right Coronary Artery Occlusion Patients subjected to elective PCI due to right coronary artery occlusion. Patients between 40 and 75 years old from the both genders History of chronic respiratory condition and PHTN 2. Patients with previous percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). 3. History of valvular surgery. 4. Patients with significant rheumatic vavular heart disease. 5. Presence of persistant arrythemia 6. Patients with End stage renal disease. 7. Patients with End stage liver disease. 8. Haemodynamically unstable patients. 9. Patients with previous Myocardial infarction. 10. Patients with Ischemic Dilated Cardiomyopathy. 11. Patients with pericardial disease. 12. Patients with congenital intra-cardiac shunt | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-70.0, Solid Tumor, Adult Histologically confirmed with mesothelin positive multiple solid tumors. 2. Failure of at least one prior standard of care chemotherapy for advanced stage disease. 3. Subjects must have measureable disease as defined by 1.1 or modified criteria. 4. Patients > 18 years of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 6. Life expectancy > 12 weeks. 7. Satisfactory organ and bone marrow function as defined by the following (of note, the minimal blood counts should be in the absence of transfusion or cytokine support): i. Absolute neutrophil count > 1,000/μl ii. Platelets >75,000/μl iii. Hemoglobin > 9 g/dL iv. Bilirubin < 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor v. Creatinine < 1.5x the institutional normal upper limit vi. Albumin ≥2 vii. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5x the institutional normal upper limit viii. Cardiac ejection fraction of >55% as measured by resting echocardiogram, with no significant pericardial effusion. 8. Blood coagulation parameters: PT such that international normalized ratio (INR) is ≤ 1.5 and a PTT < 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters. 9. Ability to understand and the willingness to provide written informed consent. 10. Male and Female subjects of reproductive potential agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) and abstain from other methods of conception during the study and for 6 months following the study cell infusion or proof of sterility Sarcomatoid MPM histology which is known in the literature to not express mesothelin; biphasic MPM is also excluded. 2. This refers to non-commercially approved investigational drugs different than those used in this protocol.Participated in any other trial in which receipt of an investigational study drug occurred within 28 days prior to enrollment and anticipated treatment with another investigational product while on study. 3. Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion of CART-meso cells. 4. Active invasive cancer other than the one of the three cancers in this study. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder and prostate cancer with PSA level < 1.0) are not excluded.CART-meso in mesothelin expressing cancers 5. HIV, HCV, or HBV infections 6. Active autoimmune disease (including but not limited to: systemic lupus erythromatosis, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within the past 4 weeks, with exception of thyroid replacement. 7. Patients with ongoing or active infection. 8. Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions. 9. Patients requiring supplemental oxygen therapy. 10. Prior therapy with gene modified cells. 11. Previous experimental therapy with SS1 moiety, murine or chimeric antibodies (human and humanized antibodies are allowed). 12. History of allergy to murine proteins 13. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) 14. Any clinically significant pericardial effusion; CHF (NY Heart Association Grade II-IV) or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study. This determination will be made by a cardiologist. 15. Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. An indwelling drainage device placed prior to enrollment is acceptable. 16. Pregnant or breastfeeding women. Female study participants of reproductive potential must have a negative urine pregnancy test of enrollment. A serum pregnancy test will be performed within 2 weeks before infusion | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Polycystic Ovary Syndrome (PCOS) Menstrual Irregularity Overweight and Obesity Aged >18 years At least 2y post-menarche BMI >18.5kg/m2 Good visibility of the ovaries on ultrasound Pelvic exam with normal results within the last 2 years Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>36 days); or Previous diagnosis of PCOS from a primary care provider Use of medication(s) known or suspected to interfere with reproductive function, metabolism, and/or appetite (e.g., oral contraceptives) within the past 3 months Use of fertility medications in the past 2 months (e.g., Clomid) Current use of a non-copper intrauterine device for contraception (e.g., Mirena) Diagnosis of premature ovarian failure, endometriosis, or another disease/disorder (other than PCOS) known or suspected to interfere with reproductive function History of ovarian surgery Missing uterus or an ovary Pregnant or breastfeeding Diagnosis of a bleeding disorder Regular use of blood thinners/anticoagulants Skin allergy/condition that might be aggravated by alcohol application | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, B-cell Malignancy B-cell Lymphoma B-Cell Acute Lymphoblastic Leukaemia CD19+ relapsed or refractory B cell malignancies Relapsed or refractory B acute lymphocytic leukemia Relapse was defined as presence of > 5% blasts at screening, or second or subsequent bone marrow relapse, or any bone marrow relapse after allogeneic stem cell transplant and must be ≥ 6 months from stem cell transplant at the time of infusion Refractory was defined by not achieving an initial complete response after 2 cycles of a standard chemotherapy regimen . Patients who were refractory to subsequent chemotherapy regimens after an initial remission were considered chemorefractory Patients with Ph+ acute lymphocytic leukemia were eligible if they are intolerant to or have not achieved a remission after two lines of tyrosine kinase inhibitor therapy, or if tyrosine kinase inhibitor therapy is contraindicated, or ineligible for allogeneic stem cell transplant because of Comorbid disease Other contraindications to allogeneic stem cell transplant conditioning regimen Lack of suitable donor Prior hematopoietic stem cell transplant Declined allogeneichematopoietic stem cell transplant as a therapeutic option Isolated extra-medullary relapse leukemia 2. Other malignancies 3. Concomitant genetic syndrome, with the exception of Down Syndrome 4. Burkitt's lymphoma/leukemia 5. Treatment with any prior gene therapy product, anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy 6. Active hepatitis B, C, or any uncontrolled infection 7. Grade 2 to 4 Graft versus Host Disease (GVHD) 8. Medications or treatments that were to be excluded Corticosteroids within 72 hours of infusion, with the exception of physiologic replacement Allogeneic cellular therapy, such as donor lymphocyte infusion within 6 weeks prior to infusion Graft versus Host Disease therapies Chemotherapy stopped prior to lymphodepletion based on clearance central nervous system prophylaxis treatment 9. Active central nervous system disease (central nervous system 2 disease [Cerebral spinal fluid containing blasts, but < 5 WBCs/microliter] patients were eligible) 10. Any condition that investigator considered may increase the risk of the subjects or interfere with the trial results | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-100.0, Diffuse Large B-cell Lymphoma(DLBCL) Mantle Cell Lymphoma (MCL) Follicular Lymphoma (FL) Subject has provided informed consent prior to initiation of any study-specific activities/procedures Age ≥ 18 at the time of informed consent Biopsy proven B-NHL including DLBCL, which also includes DLBCL that represents transformation of indolent NHL (including follicular, marginal zone, and lymphoplasmacytic lymphoma excluding chronic lymphocytic leukemia or Hodgkin Lymphoma) and DLBCL with alterations of MYC and BCL2 and/or BCL6 also described as double-hit and triple-hit lymphomas MCL Presentations of these histologies with substantial occurrence of malignant cells into the bloodstream (lymphocyte count ≥ 7 x 10^9/L) including all leukemic presentations are excluded. The following histologies are not eligible: Lymphoblastic lymphoma Burkitt lymphoma Any histologies not specifically mentioned must be discussed with the Medical Monitor Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology Subjects who received prior CD19-targeting treatment are allowed (CAR-T cell therapy is excluded). A biopsy following CD19-targeting treatment is required unless no lesions are accessible or the risk of the biopsy is deemed too high by the investigator For Part 2 (Expansion in patients with DLBCL): only biopsy proven DLBCL (biopsy proven at least at primary diagnosis), including DLBCL that represents transformation of indolent NHL (including follicular, marginal zone, and lymphoplasmacytic lymphoma excluding chronic lymphocytic leukemia or Hodgkin Lymphoma) are eligible. Other histologies are not eligible Presentations of these histologies with substantial occurrence of malignant cells into the bloodstream (lymphocyte count ≥ 7 x 10^9/L) including all leukemic presentations are excluded Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology as described in criterial Subjects who received prior CD19-targeting treatment are allowed (CAR-T cell therapy is excluded) A biopsy following CD19-targeting treatment is required unless no lesions are accessible or the risk of the biopsy is deemed too high by the investigator Treatment within 30 days prior to enrollment with another investigational device or drug (interventional clinical study / studies). Other investigational procedures while participating in this study are excluded (observational studies are permitted) Prior anti-cancer therapy as specified below At least 6 weeks must have elapsed since any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc) before the first dose of AMG 562 Other targeted anti-cancer therapy (chemotherapy, molecular targeted therapy, steroids) within 14 days or 5 half lives (which ever is longer) prior to first dose of AMG 562. Patients requiring continued treatment due to aggressive disease may only be included if there is agreement by both the investigator and the Amgen Medical Monitor Radiation therapy completed within 28 days prior to first dose of AMG 562 Autologous HSCT within six weeks prior to start of AMG 562 treatment At least 4 weeks must have elapsed since any prior treatment with antibody therapy (exception immune checkpoint inhibitors) before the first dose of AMG 562 Prior CD19-directed CAR-T cell therapies Prior allogeneic HSCT For Part 2 (Expansion in patients with DLBCL): fluorodeoxyglucose non-avid patients | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, Lymphoma, Non-Hodgkin Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 3. Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed indolent NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma [DHL/THL]), primary mediastinal (thymic) large B-cell lymphoma (PMBCL), T cell/histiocyte-rich large B-cell lymphoma (THRBCL) or follicular lymphoma grade 3B. Enough tumor material must be available for confirmation by central pathology. 4. Refractory or relapsed within 12 months from CD20 antibody and anthracycline containing first line therapy. 5. [18F] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion at screening. (Deauville score 4 or 5) 6. Adequate organ function 7. Participants must agree to use effective contraception Subjects not eligible for hematopoietic stem cell transplantation (HSCT). 2. Subjects planned to undergo allogeneic stem cell transplantation. 3. Subjects with, primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus) positive DLBCL, Burkitt lymphoma or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter transformation). 4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following noninvasive malignancies Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative Other completely resected stage 1 solid tumor with low risk for recurrence 5. Treatment with any prior gene therapy product. 6. Subjects who have received previous CD19-targeted therapy. 7. Subjects with active hepatitis B, or active hepatitis C are excluded. Subjects with negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy. Subjects with a history of or active human immunodeficiency virus (HIV) are excluded. 8. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment. 9. Active autoimmune disease requiring immunosuppressive therapy. 10. History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease. 11. History or presence of clinically relevant central nervous system (CNS) pathology 12. Pregnant or nursing (lactating) women | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-36.0, Menstrual Disorders Polycystic Ovary Syndrome Female aged 18-36years Females diagnosed with Polycystic ovarian syndrome according to Rotterdam criteria Participants willing to adopt a healthy life style and regularly practice yoga (at least 30 minutes for 5 days a week) Diabetes mellitus, Cushing's disease, hyper-prolactinemia Untreated hypo or hyperthyroidism Adrenal hyperplasia and adrenal tumour Ovarian tumour hyperthecosis History of intake of drugs aldactone/metformin or history of oral contraceptive pills (OCP) use or intake of drugs known to interfere with carbohydrate metabolism 4 weeks prior to enrolment pregnancy, breast feeding cases with any systemic disease | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Proteinosis Gallbladder Carcinoma Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls) The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Parapneumonic Effusion Empyema, Pleural Coagulopathy years old and older Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary service Pleural fluid pH <7.3 SICU placed chest tube Subsequent transfer to SICU Existing malignancy Malignant cells from initial pleural fluid sample End stage liver disease (Child's B or greater) Coagulopathy Unable to tolerate surgical procedure Frank purulent drainage (needs OR regardless) Recent surgery of abdomen or thorax precluding the use of tPA Baseline neurologic impairment requiring a proxy for consent | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Systemic Sclerosis Scleroderma Age 18 years old at the time of pre-transplant evaluation 2. An established diagnosis of systemic sclerosis 3. Diffuse cutaneous systemic sclerosis with involvement proximal to the elbow or knee and a modified Rodnan Skin Score of ≥ 14 (see Appendix A) AND Any one of the following: 1. DLCO < 80% of predicted or decrease in lung function (DLCO, DLCO/VA or FVC) of 10% or more over 12 months. 2. Pulmonary fibrosis or alveolitis on CT scan or chest x-ray (ground glass appearance of alveolitis). 3. Abnormal EKG (non-specific ST-T wave abnormalities, low QRS voltage, or ventricular hypertrophy), or pericardial effusion or pericardial enhancement without constriction on MRI 4. Gastrointestinal tract involvement confirmed on radiological study. Radiologic findings of scleroderma are small bowel radiographs showing thickened folds with dilated loops, segmentation, and flocculation +/ diverticula, or pseudodiverticula. A hide-bound appearance may be present (e.g. dilated and crowded circular folds). GI involvement may also be confirmed by D-xylose malabsorption, patulous esophagus on high-resolution computed tomography (HRCT), or esophageal manometry. OR Limited cutaneous systemic sclerosis (SSc) (modified Rodnan Skin Score <14) with lung involvement defined as active alveolitis on bronchoalveolar lavage (BAL), ground-glass opacity on CT scan, a DLCO < 80% predicted, or decrease in lung function (DLCO/VA, DLCO, FVC) of 10% or more in last 12 months. Other for "CAST" Conditioning Regimen (presence of any of the following): 1. Septal flattening or D-sign on MRI (without deep breathing) 2. PASP >40 mm Hg or >45 mm Hg with fluid challenge* 3. mPAP >25 mm Hg or >30 mm Hg with fluid challenge* 4. Non-ischemia diffuse ventricular hypokinesis or non-ischemia wall hypokinesis Fluid challenge is 1000 ml normal saline over 10 minutes. Fluid challenge will not be done if right atrial pressure is >13 mm Hg at rest or pulmonary capillary wedge pressure is >20 mm Hg at rest Active ischemic heart disease or untreated coronary artery disease 2. Untreated life-threatening cardiac arrhythmia on EKG or 24-hour holter 3. Pericardial effusion > 1 cm on cardiac MRI unless successful pericardiocentesis has been performed 4. LVEF <35% 5. End-stage lung disease characterized by TLC<45% of predicted value, or DLCO hemoglobin corrected < 30 % predicted. 6. Creatinine clearance <40 by 24-hour urine 7. History of breast implants that have not been removed (unless they cannot be surgically removed due to risks of surgery) 8. Liver cirrhosis, transaminases >2x of normal limits, or bilirubin > 2.0 unless due to Gilbert's disease 9. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment 10. Prior history of malignancy 11. Positive pregnancy test, inability or unable to pursue effective means of birth control, or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy 12. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible 13. Major hematological abnormalities such as platelet count < 100,000/ul or absolute neutrophil count (ANC) < 1000/ul 14. HIV positive 15. Hepatitis B or C positive 16. PASP >50 mmHg without fluid challenge 17. mPAP >34 mmHg without fluid challenge 18. Coronary artery disease not reversed by cardiology and interventional radiology | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Tachycardia Ventricular Arrythmia Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines[1] 2. Patient is willing and able to sign and date the Informed Consent Form. 3. Patient is at least 18 years of age and meets age requirements per local law 4. Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up [1] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias - Patient has indications for bradycardia pacing [1] or Cardiac Resynchronization Therapy (CRT) [2] (Class I, IIa, or IIb indication) 2. Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads 3. Patient has anatomical abnormality that significantly increases implant risk[3] including: • Severe obesity [4] Marked RV dilation Marked sternal abnormality Hiatus hernia that distorts mediastinal anatomy 4. Patient has prior chest radiotherapy 5. Patient had previous mediastinitis 6. Patient had previous coronary artery bypass grafting procedure 7. Patient has existing transcatheter aortic valve replacement 8. Patient has gastrostomy tube 9. Patient has had a prior sternotomy, prior mediastinal instrumentation, prior abdominal surgery in the epigastric region, or planned sternotomy 10. Patient has previous pericarditis that: • Was chronic and recurrent, or • Resulted in pericardial effusion [5], or • Resulted in pericardial thickening or calcification [6] 11. Patients with a medical condition that precludes them from undergoing defibrillation testing, such as: • known LV thrombus • decompensated heart failure LVEF <20% [7] other physician discretion 12. Patient has persistent Atrial Fibrillation who is at high risk of a thromboembolic event with a CHA₂DS₂-VASc score ≥3, or is contraindicated for having anticoagulation interrupted for ≥72 hours 13. Patients with comorbidities which may increase surgical risk of complications[8] including: • severe aortic stenosis COPD and is oxygen dependent Hepatosplenomegaly Marked hepatomegaly 14. Patient is on renal dialysis 15. Patient with any evidence of active infection or undergoing treatment for an infection 16. Patient with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. 17. Patients with a limited life expectancy of less than 12 months 18. Patient is enrolled or planning to enroll in a concurrent drug or device study that may confound the results of this study, without documented pre-approval from a Medtronic study manager 19. Patient with any as required by local law (e.g., age, pregnancy, breast feeding) 20. Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence [9] [1] 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing). [2] ACC/AHA/HRS guidelines for Cardiac Resynchronization Therapy [3] Per physician discretion [4] BMI > 40 [5] As documented on echo or MRI [6] As documented on CT scan or MRI [7] Most recent LVEF in the last 180 days (inclusive) [8] Per physician discretion [9] if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to EV ICD Pilot Study procedures - | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-90.0, Heart Failure With Normal Ejection Fraction presence of typical HF symptoms and signs 2. LV ejection fraction ≥ 50 3. elevated levels of NT-proBNP (at least >125 pg/ml) 4. echocardiographic structural (a left atrial volume index > 34 mL/m2 or a left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or functional alterations (E/e'≥13 and a mean e' septal and lateral wall < 9 cm/s) chronic renal failure (creatinine > 250 μmol/L) 2. significant hepatic disease, significant coronary artery disease (CAD) (coronary artery stenosis >70% without intervention or positive stress test), 3. secondary hypertension, 4. pericardial disease 5. significant valvular heart disease (>mild stenosis, >moderate regurgitation), 6. active cancer, 7. cor pulmonale 8. congenital heart disease 9. high-output heart failure 10. subjects receiving long-term treatment with phosphodiesterase 5 in-hibitors 11. chronic atrial fibrillation | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Cholecystitis Adult> 18 years old Ability to accept consent Acute documented cholecystitis (pain> 6h, thickening of vesicular wall on ultrasound, biological inflammatory syndrome) Patient operated within 5 days of onset of signs Surgery decided by laparoscopy Pregnant woman Atcd umbilical abdominal surgery Achievement of the open subcostal intervention Patient under anticoagulant Patient ASA3 Age <75 years BMI> 45 icteric cholestasis on preoperative laboratory examination | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, Diffuse Large B-Cell Lymphoma, Unspecified Site Previously untreated CD20 Positive DLBCL. 2. International Prognostic Index (IPI) score of 0 to 2, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. 18 years to 70 years; Male or female patients; Body Mass Index (BMI)≤2.13 m^2. 4. Expected survival more than 6 months. 5. At least 1 bi-dimensionally measurable lesion: Nodal lesion: Greatest transverse diameter≥1.5cm and short axis≥1.0cm; Extra-nodal lesion: Greatest transverse diameter≥1.0cm. 6. Cardiac echocardiography: LVEF≥50%. 7. Adequate hematological function: WBC≥3 x 10^9/L, HGB≥80g/L, ANC≥1.5 x 10^9/L, PLT≥75 x 10^9/L. 8. Hepatic function: TBIL≤1.5 x ULN, ALT or AST≤2.5 x ULN, ALP≤3 x ULN if with no bone marrow infiltration, Renal function: Cr≤1.5 x ULN. 9. Seronegative for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated. 10. Must agree to take effective birth control methods or are not of childbearing potential. Women must agree to continue contraceptive measures within 12 months after the last treatment. Men must agree to continue contraception within 3 months after the treatment. 11. All patients must have signed an informed consent document Other types of DLBCL: primary central nervous system DLBCL, primary skin DLBCL (leg type), EBV-positive DLBCL, NOS, EB virus-positive skin mucosal ulcer, chronic inflammation-related DLBCL, lymphomatoid granuloma, primary Mediastinal (thymus) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, plasmablastic lymphoma, primary exudative lymphoma, HHV8+DLBCL, NOS, Burkitt's lymph Tumor, primary testicular lymphoma。 2. Confirmed DLBCL with BCL-2 and c-MYC gene rearrangement or BCL-2, BCL-6, and c-MYC gene rearrangement by FISH. B-cell lymphomas, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma. 3. B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma. 4. Previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer. 5. Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy); 6. Patients who received continuous treatment of corticosteroid drugs lasting for more than 10 days. Prednisone with the dosage over 30mg/day; Other corticosteroid drugs with equal dosage. 7. Patients who received cytotoxic drugs or anti-CD20 monoclonal antibody for other diseases (such as Rheumatoid arthritis).Or received any monoclonal antibody within 3 months prior to the enrollment of the study. 8. Patients who participated in other clinical trials within 3 months prior to the enrollment of the study. 9. Patients who received attenuated or live virus vaccine within 1 month prior to the enrollment of the study. 10. Patients who received hematopoietic stimulating factors within 1 week prior to the enrollment of the study. 11. Recent major surgery within 1 month. 12. Active Infectious disease or significant infections requiring intravenous antibiotic therapy or hospitalization in the past 4 weeks (exception of tumor induced fever). 13. Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins. 14. Contraindicative to any drug in CHOP. 15. Patients who have significant cardiac disease, including heart disease of grade Ⅲ of Ⅳ according to the New York Heart Association(NYHA) system, or occurrence of myocardial infarction, unstable arrhythmia, unstable angina or severe hypertension in the past 6 months or peripheral nervous system(PNS) or CNS disease. 16. Suspected active tuberculosis patients. 17. Patients with serious peripheral nervous system or central nervous system disease. 18. Patients that researchers deem as not appropriate to enter the study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Cystinuria Patients with a confirmed laboratory diagnosis of cystinuria who meet the following (1) stone analysis demonstrating cystine as a component, or (2) increased urinary cystine excretion (>250mg/24hrs in adults) A medical regimen that includes Tiopronin Willing to use a medically accepted form of birth control, if female and of child bearing potential Ability to reliably urinate in a collection vessel and measure urine volume Ability to give informed consent Documentation of a stable complete blood count (CBC) and urinalysis (UA) in the six month period prior to the date of enrollment Enrollment in Rare Kidney Stone Consortium (RKSC) Protocol 6401 (Cystinuria Registry) Women who are pregnant, breastfeeding, or trying to become pregnant Patients with renal colic Patients who are scheduled to undergo a surgical procedure Inability to give informed consent | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 20.0-40.0, Deficiency, Vitamin D Diabetes, Gestational Singleton pregnancy Aged in 20-40 years Gestational age 24-28 weeks Non-history of acute or chronic diseases History of GDM Type 1 and 2 diabetes mellitus Preeclampsia Polycystic ovary syndrome Thyroid disease Parathyroid disease Metabolic bone disease Kidney disease Abnormal liver function Multiple pregnancy, or | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-55.0, Acute Myeloid Leukemia Acute Lymphocytic Leukemia Biphenotypic/Undifferentiated Leukemia Chronic Myelogenous Leukemia Myelodysplasia Relapsed Large Cell Lymphoma Mantle Cell Lymphoma Hodgkin Lymphoma Burkitt Lymphoma Relapsed T-Cell Lymphoma Lymphoplasmacytic Lymphoma Age, Unit Cell Dose and HLA Match Subjects must be ≤55 years of age Subjects must weigh >11 kg Subjects must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose >1.0 x 107 per kilogram recipient weight. HLA matching is initially based on a minimum of 5 of 8 HLA alleles at high resolution A, B, C, DRB1 typing; searches will be performed according to the current Magenta Cord Blood Search Algorithm. Eligible Diseases Acute myelogenous leukemia (AML) in morphological complete remission with Minimal residual disease (MRD) by flow cytometry, or Intermediate to high risk leukemia in first (CR1) based on institutional eg. not favorable risk AML which is defined as having one of the following t(8,21) without cKIT mutation inv(16) or t(16;16) without cKIT mutation Normal karyotype with mutated NPM1 but FLT3-ITD wild type Patients with a HLA matched sibling donor or a HLA matched unrelated donor who is available for marrow or peripheral blood stem cell collection at the desired time of transplant Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology Active bacterial, viral or fungal infection (currently taking medication and persistence of clinical signs and symptoms) with a minimum of 4 weeks of anti-fungal treatment Prior autologous or allogeneic transplant Other active malignancy Subjects >2 3 years of age unable to receive TBI 1320 cGy due to extensive prior therapy including >12 months alkylator therapy or >6 months alkylator therapy with extensive radiation, or prior Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, Crohn's Disease Male and Female subject at ≥18 and ≤ 75 years of age at randomization Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450 Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula Treatment naïve subjects diagnosed with Crohn's disease, (without previous exposure to treatment) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 10.0-45.0, Hiv Meningitis, Meningococcal HIV Infections Any 10-45-year old male or female patients with confirmed HIV infection where they (or someone with parental responsibility) can sign fully informed consent and are able to comply with study requirements Pregnancy or breast feeding History of MenACWY (Menveo® or Nimenrix®) and 4CMenB (Bexsero®) vaccination in the previous 2 years Receipt of other non-live vaccines within 2 weeks and live vaccines within 4 weeks of first dose, planned receipt of vaccine within 2 weeks of study visits Current active malignancy Known latex allergy Known or suspected hypersensitivity to any components of the vaccines or history of severe allergic reaction after previous vaccination Bleeding disorder preventing IM vaccination Any acute or chronic illness which according to the investigators judgement would prevent patients to receive the vaccines or participate in the study Participation in clinical trials concerning investigational medical product within 0 days or before completion of the study Children in care | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 12.0-999.0, Meningitis Encephalitis Guillain-Barré Subarachnoid Hemorrhage Intracranial Neoplasm Intracranial CNS Disorder Patients age 12 years and older who need lumbar puncture (LP) for diagnostic purposes or patients already underwent LP but failed to obtain Cerebrospinal Fluids i.e. "Unsuccessful Tap" Patients younger than 12 years of age | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Mantle Cell Lymphoma Confirmed diagnosis of mantle cell lymphoma with CD20 positivity in tissue biopsy MCL patients must have a clinical indication to start systemic therapy. Symptoms and features of MCL any of the following: a) B-symptoms, b) Mantle Cell Lymphoma International Prognostic Index (MIPI) > 3, c) Ki 67 >= 30%, d) bulky tumors > 10 cm or in case of >= 2 tumors, each >= 5 cm in diameter, e) disease threatening organ function, f) elevated lactate dehydrogenase (LDH), g) peripheral blood (PB) white blood cell (WBC) > 50,000, h) pancytopenia due to bone marrow MCL, i) patient's choice due to anxiety; j) pain due to lymphoma; k) somatic mutations in the TP53, NSD2 or NOTCH genes; l) size of spleen >= 20 cm Newly diagnosed MCL with no prior therapy Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study Bi-dimensional measurable disease using both computed tomography (CT) scan and/or positron emission tomography (PET)-CT or gastrointestinal biopsies, CT gastrointestinal, bone marrow or spleen only patients are allowable Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Absolute neutrophil count (ANC) >= 1000/mm^3 independent of growth factor support Platelets >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement without necessitating transfusion Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, laboratory abnormality, or psychiatric illness that, in the investigators opinion, places the patient at unacceptable risk or would prevent the subject from signing the informed consent form Pregnant or breast-feeding females Known human immunodeficiency virus (HIV) infection (HIV testing is not required) Evidence of other clinically significant uncontrolled condition(s) including, but not limited to Uncontrolled and/or active systemic infection (viral, bacterial or fungal) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface [HBs] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core [HBc] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate Treatment with any of the following within 7 days prior to the first dose of study drug Steroid therapy for anti-neoplastic intent Moderate or strong cytochrome P450 3A (CYP3A) inhibitors Moderate or strong CYP3A inducers | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, Mental Stress Hypertension Diabetes Criteria:Eligible patients are referred to the study through the treating MOH physicians at the health centers. Through an initial screening process, patients will be assessed for via inclusion/ by trained nurses. As stated, the nurses will be trained in the data collection procedures by the Research Manager and potential subjects will be fully informed that they can still receive health care services even if they have no interest in participating in the research. This information will be received through the patient information and self-report. 1. (at least two of the following) Obesity, defined as BMI ≥ 30 Fasting blood glucose ≥ 100 ml/dl Systolic blood pressure ≥ 120 mmHg and/or diastolic blood pressure ≥ 80 mmHg Self-reported uncontrolled dyslipidaemia, cholesterol >240, LDL >190, HDL < 40 ad/or TG >500 Asthma Diabetes Hypertension Renal dysfunction: also known as renal insufficiency or renal failure; assessed by self-report Heart failure: also known as congestive heart disease or chronic heart failure; assessed by self-report | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Recurrent B Acute Lymphoblastic Leukemia Refractory B Acute Lymphoblastic Leukemia Pre-registration (Step 0) Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy Registration (Step 1) Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation Philadelphia chromosome/BCR-ABL1-negative ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR). If any test is positive for Philadelphia chromosome/BCR-ABL1, then the patient is ineligible No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion Categories of CNS Involvement for CNS Evaluation Prior to Registration | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma, Non-Hodgkin Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Disorder Age ≥ 18 years at the time of consent Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT Positron-emission tomography-positive disease by Lugano Classification Eastern Cooperative Oncology Group performance status of 0 to 1 Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function Adequate vascular access for leukapheresis procedure Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy Subjects must agree to use appropriate contraception Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study) History of prior allogeneic hematopoietic stem cell transplant Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis History of another primary malignancy that has not been in remission for at least 2 years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on a Papanicolau smear Active hepatitis B or hepatitis C infection at the time of screening History of or active human immunodeficiency virus infection at the time of screening Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel administration Presence of acute or chronic graft-versus-host disease History of clinically significant cardiac conditions within the past 6 months History or presence of clinically relevant CNS pathology such as epilepsy/seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 12.0-999.0, Chronic Kidney Diseases Alport Syndrome Autosomal Dominant Polycystic Kidney Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial Meets the following based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable: 1. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR <20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline > 1.0 ml/min/1.73m2 per month in the 3 months prior to assessment may not be eligible); 2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable; 3. No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after the last study drug dose Women who are pregnant or breastfeeding Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason Known hypersensitivity to any component of the study drug | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Cartilage Damage Knee Injuries Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible Minimal age 18 years (Preferred age group >40 years) Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion Informed consent Under age (<18yrs) Active or recent (<1 yr) septic arthritis of the involved knee Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee (Severe) osteoarthritis in the involved or other compartments of the involved knee Severe osteoporosis MRI not possible (eg. due to pacemaker) Marked valgus or varus alignment (>6 degrees) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 5.0-15.0, Metabolic Syndrome Cancer survivors Treatment with chemotherapy and/or radiation therapy for a primary ALL/NHL diagnosed prior to age 17 years ≤ 15 years of age at the time of enrollment No cytostatic drugs uptake during the study Diagnosis of diabetes mellitus types 1 or 2 types before antitumor therapy Active oncological disease History of allogeneic hematopoietic cell transplant The renouncement of participation from the patient or legally authorized representative | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma Leukemia Must be ≥ 18 years of age Histologic diagnosis of Burkitt Lymphoma/Leukemia or high-grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6 confirmed at enrolling institution Failure of at least one previous line of therapy Failure after prior bone marrow transplant, or ineligible for or opted not to participate in bone marrow transplantation for Burkitt Lymphoma/Leukemia, or DHL/THL ECOG Performance Status of ≤ 3 Measurable disease as defined RECIL (2017) or isolated bone marrow involvement Patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with anti-cancer drugs, radiotherapy or other anti-cancer modalities. Patients with persistent, non-hematologic, non-infectious toxicities from prior treatment must have documented resolution to ≤ Grade 2 Patients must have, or be willing and eligible to undergo placement of, a working central venous access device Venous access available (e.g., portacath, PICC line or equivalent) Laboratory values obtained ≤ 2 weeks prior to enrollment must demonstrate adequate hepatic function, renal function, and coagulation as defined below Patients that have received a chemotherapy regimen with stem cell support in the previous 2 months Any medical condition that is clinically unstable despite present therapy (i.e. uncontrolled infection) Platelets < 50,000/mm3 unless attributable to marrow based (either Burkitt lymphoma or DHL/THL.) Note: Patients with leukemia/lymphoma in the marrow 25,000-50,000 will be assessed for grade 4 thrombocytopenia unless they have platelet recovery above grade 3. Patients entering with platelets <25,000 will only be assessed for thrombocytopenia related to drug if they recover to grade 3 or higher Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, coronary artery disease, myocardial infarction within the past 3 months, uncontrolled cardiac arrhythmia, pericardial disease or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patient's risk for toxicity Patients with active central nervous system (CNS) parenchymal disease. Patients with leptomeningeal disease are allowed as long as the CSF has cleared for more than 4 weeks and the patient is receiving maintenance intrathecal/intra Ommaya therapy Any active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease) Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety HIV patients with any of the following: a) uncontrolled HIV infection defined as an HIV viral load > 100K copies/mL, b) a documented opportunistic infection within the last 90 days, c) concurrent HIV therapy with zidovudine or any strong CYP3A4 inhibitor (e.g. ritonavir or cobicistat) within 7 days of study drug due to potential drug-drug interaction Patients who have received radiotherapy, surgery, treatment with cytotoxic agents, treatment with biologic agents, immunotherapy , or any other anti-cancer therapy for any kind for cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of CPI-613 treatment with the of radiation to one area (e.g. whole brain or involved nodal site) that does not interfere with response assessment in other sites. A course of steroids (up to 14 days total) prior to study initiation is acceptable Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 35.0-75.0, Renal Transplantation Aging are group specific. HBV, HCV and HIV testing are not necessary in the RT groups as all RT recipients are tested prior to transplant. The investigators will not restrict volunteers with respect to gender, ethnic or racial group. Groups 1 (65-75 yrs) and 2 (35-45 yrs) Renal Transplant populations End stage renal disease cause either DM2 and/or hypertension (HTN) Renal transplant >12 months ago Group 3: Diabetic/hypertensive 65-75 year old controls With DM2 and/or HTN Previous immunization with PPV23 >1 year prior Willingness to be tested for HIV, HBV and HCV "normal kidney function" defined as glomerular filtration rate (GFR) of 60% or above Group 4: Healthy Control 65-75 yr old Without DM2 May have high blood pressure (systolic>140 and/or diastolic>90) as long as it is well controlled (systolic<140 and/or diastolic <90) and has not affected kidney function Previous receipt of PPV23 > 1 year prior are either applicable to all groups or group specific. Therefore we have listed the applicable to ALL groups first. Group specific are listed under each group common to all groups Previous immunization with PCV13 Pregnancy, no contraceptive practice in women of childbearing age, or breastfeeding Known anaphylaxis, hypersensitivity or "bad allergic reaction" to the pneumonia vaccine. This does not egg allergy or previous Guillan Barre syndrome Those who received blood products or gamma globulin within 3 months Inability to comprehend or sign the informed consent form Previous/present illness that may affect immune response to the vaccine previous pneumococcal disease | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-25.0, Acute Leukemia Acute Myeloid Leukemia Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Mixed Lineage Leukemia Lymphoblastic Lymphoma Burkitt Lymphoma Juvenile Myelomonocytic Leukemia Age: Patients <25 years. 2. First allogeneic HSCT only. 3. Disease Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk cytogenetics, or relapse. Hematologic malignancies including: acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, mixed lineage or bi-phenotypic leukemia, lymphoblastic or Burkitts, juvenile myelomonocytic leukemia 4. Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP). 5. Signed consent by parent/guardian or able to give consent if >18 years Patients who do not meet institutional disease, organ or infectious 2. No suitable donor available for mobilized peripheral stem cells 3. Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects. 4. Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma Donor selection and 1. Unrelated donor meets National Marrow Donor Program for donation 2. HLA testing/matching 3. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-22.0, Hypertension Prehypertension Obesity Overweight Left Ventricular Hypertrophy Elevated Blood Pressure Children and young adults with overweight or obesity referred for evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University are eligible Children who are wards of the state or who are non-English speaking without an in-person interpreter accompanying them to the clinic visit | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Renal Cell Carcinoma Urothelial Carcinoma Cervical Cancer Ovarian Cancer Recurrent Endometrial Cancer Be willing and able to provide written informed consent/ for the trial. 2. Be at least 18 years of age on day of signing informed consent, male or female. 3. Patients with one of the following tumors Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (defined as more than 50% clear cell component) after failure of IL-2 and/or anti-VEGF TKI treatment. If patients didn't want to use anti-VEGF TKI medicine or couldn't stand anti-VEGF TKI medicine costs, they will also be considered Histologically or cytologically confirmed diagnosis of unresectable urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra (defined as more than 50% transitional cell component) after failure of no more than two prior platinum-based chemotherapeutic regimen Histologically or cytologically confirmed diagnosis of advanced squamous cell carcinoma of the cervix after failure of first-line system treatment Histologically confirmed diagnosis of recurrent or refractory epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that are relapsed and resistant (recurred less than 6 months after chemotherapy) or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen Histologically confirmed diagnosis of recurrent or refractory endometrial cancer that are relapsed and resistant or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen. 4. At least one measurable lesion according to 1.1. 5. The patients can swallow pills. 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. 7. Life expectancy of at least 12 weeks. 8. The results of patients' blood tests are as follows:-Neutrophils≥1.5E+9/L; - Plt≥90E+9/L; -Hb≥90g/L; -ALB≥30g/L ;-TSH≤1×ULN;-TBIL ≤ 1 ×ULN;-ALT and AST ≤ 3 ×ULN; AKP≤ 2.5×ULN; -Creatinine ≤ 1.5×ULN. 9. Male or Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. 2. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. 3. Known history of hypersensitivity to other antibody formulation. 4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to trial treatment. 5. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg. 6. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to（1）Congestive heart failure (New York heart association (NYHA) class > 2)；（2）unstable or severe angina; （3）myocardial infarction within 12 months before enrollment；（4） ventricular arrhythmia which need medical intervention.（5）QTc>450ms（male）/QTc>470ms (female)； 7. Coagulation abnormalities (INR>2.0、PT>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy. 8. Bleeding history, having bleeding event（≥3 Grade according CTCAE 4.0 ）within 4 weeks before screening. 9. Tumor invasion around major vessels shown by imaging, high risk of major vascular invasion leading to massive hemorrhage judged by investigators. 10. Previous Arterial/venous thrombosis events within 6 months. 11. Known hereditary or acquired bleeding and thrombosis tendency. 12. Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g. 13. Prior chemotherapy, radiotherapy, surgery therapy within 4 weeks or palliative radiotherapy within 2 weeks or target therapy within 5 half-life of the drug before the study drug administration, or any unresolved AEs > Common Terminology for Adverse Events (CTCAE) Grade 1. 14. Active infection or an unexplained fever > 38.5°C within 7 days before the study drug administration, or baseline WBC>15×E+9/L . 15. Has known history of Interstitial lung disease, or using steroids evidence of active, non-infectious pneumonitis, or would interfere with the detection and handling of suspicious drug-related pulmonary toxicity. 16. History of immunodeficiency or human immunodeficiency virus (HIV) infection. 17. HBV DNA>500 IU/ml，HCV RNA>1000copies/ml，HBsAg+ and anti-HCV+； 18. Has a known additional malignancy within the last 5 years, or that is progressing or requires active treatment. Exceptions basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or patients with recurrent ovarian cancer has a known additional breast cancer that has been radical mastectomy and doesn't relapse within 3 years. 19. Patients with treatment history of SHR-1210 or any other PD-L1 or PD-1 antagonists or famitinib. 20. Patients who may receive live vaccine during the study, or previous had vaccination within 4 weeks. 21. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's safety and participate in the study or would interfere with the interpretation of the results or lead to the trial being terminated early | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 22.0-999.0, Rhytides Wrinkle Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles. 2. Able to read, understand and voluntarily provide written Informed Consent. 3. Able and willing to comply with the treatment/follow-up schedule and requirements. 4. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline Implantable defibrillators, cardiac pacemakers, and other metal implants 2. Subjects with any implantable metal device in the treatment area 3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 5. Current or history of any kind of cancer, or pre-malignant moles. 6. Severe concurrent conditions, such as cardiac disorders. 7. Pregnancy or intending to become pregnant during the study and nursing. 8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. 9. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion. 10. Poorly controlled endocrine disorders, such as diabetes. 11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 12. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin). 14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. 15. Use of isotretinoin (Accutane®) or other systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion. 16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session. 17. Any surgical procedure in the treatment area within the last six months or before complete healing. 18. Treating over tattoo or permanent makeup. 19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks. 20. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Atrial Fibrillation Patients with inferior STEMI who will undergo PPCI (primary percutaneous coronary intervention ) -A history of preexisting AF Prior documentation of heart failure or reduced left ventricular ejection fraction < 50% Severe valvular disease ( rheumatic , sclerotic ) or secondary to AMI Left ventricular hypertrophy : enlargement and thickening of the walls of the ventricle Patients with inferior STEMI treated with intravenous thrombolysis or conservative strategy Patients with inferior STEMI who undergo primary PCI and associated with right ventricular or posterior infarction History of pulmonary embolism or COPD ( chronic obstructive pulmonary disease ) Those with thyrotoxicosis | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Adult Patients With Suspected Meningitis and/or Encephalitis suspected or confirmed infectious meningitis and/or encephalitis as principal and/or secondary diagnosis from January 2006 to December 2017 patients with the diagnosis of meningitis/encephalitis confirmed prior to hospital admission | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 2.0-999.0, Burkitt Lymphoma KSHV-associated Multicentric Castleman Disease Diffuse Large B-Cell Lymphoma Histology and immunohistochemistry (CD20+) confirmed Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBCL), or histology confirmed KSHV-associated multicentric Castleman disease with elevated blood KSHV viral load Cohort 1: Age should be equal to or greater than 15 Cohort 2: Age: 2-15 Measurable disease Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Able to provide informed consent (adults) or assent (children < 18 years) in English or Luganda Human immunodeficiency virus (HIV)-infected patients eligible if meet the following CD4+ T-cell count > 200 cells/uL HIV treatable with effective antiretroviral therapy that does not agents with known significant drug-drug interactions with accompanying chemotherapy (ritonavir and cobicistat contraindicated) Previous therapy for lymphoma or KSHV-multicentric Castleman disease (MCD) History of hypersensitivity to rituximab Pregnant or nursing women. Men or women may not participate unless they have agreed to use effective contraception during treatment and for 12 months following completion of therapy Inadequate organ function, unless attributed to lymphoma or KSHV-MCD Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 times upper limit of normal Creatinine > 2 times upper limit than normal or calculated creatinine clearance < 60 mL/min New York Heart Association (NYHA) cardiac failure class III or IV Patients with clinically significant anemia-hemoglobin less than 10 g/dL Central nervous system (CNS) masses consistent with lymphoma or untreated infection; leptomeningeal disease will not be excluded Patients with malignancy within 5 years, other than resected local skin cancer or limited Kaposi sarcoma (KS) (no known pulmonary KS) | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, B-cell Non Hodgkin Lymphoma Refractory/relapsed B-NHL (including malignant transformation like Richter's transformation) with no available approved standard therapy. Including, but not restricted to: 1. Diffuse large B cell lymphoma (DLBCL): relapsed/refractory disease after ASCT or ineligible for ASCT after first-line therapy; transformation from CLL, SLL or FL allowed 2. Follicular lymphoma: at least 2 prior regimens and progression <2 years after most recent line of therapy 3. Mantle cell lymphoma: beyond 1st CR with relapsed disease, progressive disease during first-line rituximab chemotherapy, or persistent disease after first-line rituximab-chemotherapy and not eligible or appropriate for conventional therapy, ASCT or relapsed after prior autologous SCT, prior therapies including ibrutinib if not contraindicated 4. CLL and SLL: after at least two lines of treatment including btk inhibitor ibrutinib and bcl2 inhibitor venetoclax (if not contraindicated), patients must have been refractory to at least one of the substances Patients with 1b-d will only be eligible for Part I, dose cohort 1. 2. Patients in cohort 1a must have histologically confirmed DLBCL and associated subtypes with relapse or refractory disease after first line chemo-immunotherapy and be ineligible for HSCT 3. Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification DLBCL not otherwise specified (NOS) High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B Aggressive B-cell lymphoma T-cell/histocyte rich B-cell lymphoma Primary mediastinal B-cell lymphoma EBV+ DLBCL Transformed lymphoma (e.g. transformed follicular or marginal zone lymphoma) 4. First line chemo-immunotherapy is defined as therapy containing the combination of CD20 targeted immunotherapy and cytotoxic chemotherapy. 5. Chemotherapy-refractory disease is defined as one or more of the following No response to first line of therapy PD as best response to first line therapy regimen Eastern Cooperative Oncology Group (ECOG) performance status >2 2. Absolute neutrophil count (ANC) <1,000/µL 3. Platelet count <50,000/µL 4. Absolute lymphocyte count <100/µL 5. Presence of leukemia/lymphoma cells in peripheral blood 6. Primary CNS lymphoma 7. Unable to give informed consent 8. Known history of infection with human immunodeficiency virus (HIV) or active infection with hepatitis B (HGsAg positive) 9. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative 10. Known history or presence of seizure activities or on active anti-seizure medications within the previous 12 months 11. Known history of CVA within prior 12 months 12. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease 13. Presence of CNS disease that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity 14. Active systemic fungal, viral or bacterial infection 15. Clinical heart failure with New York Heart Association class ≥2 or LVEF <30% 16. Resting oxygen saturation <90% on room air 17. Liver dysfunction as indicated by total bilirubin, AST and/or ALT >5 x institutional ULN, unless directly attributable to patient's tumor 18. CrCl <30 mL/min calculated according to the modified formula of Cockcroft and Gault or by direct urine collection 19. Pregnant or breast-feeding woman 20. Active secondary malignancy requiring treatment 21. Medical condition requiring prolonged use of systemic corticosteroids >10 mg/day 22. Concurrent radiotherapy (allow up to time of leukapheresis) 23. Baseline dementia that would interfere with therapy or monitoring, determined using mini-mental status exam at baseline 24. History of severe immediate hypersensitivity reaction against any drug or its ingredients/impurities that is scheduled to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication/salvage therapies for treatment related toxicities 25. Patients in which such medication (see criterion 24) is contraindicated for other reasons than hypersensitivity (e.g. live vaccines and fludarabine) 26. Refusal to participate in CAR-T long-term follow-up (LTFU). 27. Refusal to undergo core needle biopsy or fine needle aspiration of tumor on day 2-5 after MB-CART infusion and at time of disease progression and relapse | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma, B-Cell Histologically confirmed CD19+ Large B-Cell Lymphoma including Diffuse Large B-cell Lymphoma (DLBCL) not otherwise specified (including de novo and transformed lymphoma), Primary Mediastinal Large B-cell Lymphoma, High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangement per WHO 2016 classification Relapsed or refractory disease after greater than 2 lines of therapy including anthracycline and anti-CD20 therapy and either having failed autologous stem cell transplant (ASCT) or being ineligible for ASCT ECOG 0-1 Adequate organ function Prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, adoptive cell transfer of any kind, including CAR T cells Active central nervous system (CNS) lymphoma involvement History or presence of clinically relevant CNS pathology Active inflammatory neurological disorders, autoimmune disease, or infections | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-18.0, Meningitis/Encephalitis Residual cerebrospinal fluid samples after routine tests Samples obtained by lumbar puncture Sample volume is not less than 0.5 mL Samples that have not been centrifuged Samples from repeatedly enrolled patients Samples that have not been preserved as required | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, Syncope, Vasovagal At least one documented spontaneous VVS during preceding 12 months or one syncope in history leading to injury and minimum 2 presyncopal events during preceding 12 months, refractory to all recommended types of standard treatment In case of lack of ECG documentation during spontaneous syncope and history suggesting reflex syncope, at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block with syncope or bradycardia <40 beats per minute with syncope or presyncope during baseline tilt test Sinus rhythm during ECG and tilt test Significantly decreased quality of life due to syncope Positive response to atropine test Obtained written informed consent Other possible and treatable causes of syncope such as significant cardiac disease, cardiac arrhythmia or abnormalities of vertebro-basiliar arteries History of stroke or TIA History of cardiac surgery Contraindications to ablation in the right or left atrium | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Heart Failure Aged 18 years and older Patients with confirmed diagnosis of HF Diagnosis is made by the treating physicians according to local practices and their clinical judgement • Concomitant participation in any/a clinical trial with any investigational treatment during the index hospitalization | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Tick Borne Encephalitis years or older clinical picture compatible with tick-borne encephalitis clear cerebrospinal fluid cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus positive serum IgG antibodies against Lyme borreliae isolation of B.burgdorferi sensu lato from cerebrospinal fluid positive intrathecal borrelial antibody production index seroconversion of borrelial IgG antibodies presence of erythema migrans and/or borrelial lymphocytoma in the last month Bannwarth syndrome | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Tick Borne Encephalitis Lyme Disease age ≥18 years admitted between January 2007 and December 2013 at the University Medical Centre Ljubljana, Slovenia tick-borne encephalitis defined according to European (febrile illness with symptoms and/or signs of meningitis or meningoencephalitis, cerebrospinal fluid (CSF) pleocytosis (>5 × 106 cells/L), and demonstration of acute TBE virus infection (the presence of specific tick-borne encephalitis virus IgM and IgG antibodies in serum or demonstration of intrathecal production of specific TBE virus IgM and/or IgG antibodies in patients previously vaccinated against tick-borne encephalitis) Lyme borreliosis in the past | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Diffuse Large B-Cell Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Double-Expressor Lymphoma EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements High Grade B-Cell Lymphoma, Not Otherwise Specified Neoplastic Cells With Double Expression of MYC and BCL2 Proteins Present Pathologic diagnosis of diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma (HGBCL). Eligible subtypes DLBCL not otherwise specified (NOS), Epstein Barr Virus positive (EBV+) DLBCL, and DLBCL/HGBCL transformed from an underlying indolent B-cell lymphoma. Patients with T-cell/histiocyte rich large B-cell lymphoma and primary mediastinal B-cell lymphoma are not eligible Double hit lymphoma (DHL) or double expressing lymphoma (DEL) DHL is defined as high grade B-cell lymphoma with one of the below Translocations of MYC and BCL2 Translocations of MYC and BCL2 and BCL6 (triple hit lymphoma) Translocations of MYC and BCL6 without BCL2 translocation BUT with immunohistochemistry (IHC) expression of BCL2 (>=50%) DEL is defined as DLBCL or high grade B-cell lymphoma not otherwise specified (NOS) with protein expression by IHC of both MYC (>= 40%) and BCL2 (>= 50%) in the absence of dual translocations of both MYC and BCL2). (Double Expressing Lymphoma, DEL). Local determination of fluorescence in situ hybridization (FISH) and IHC will be performed per standardized guidelines and will be acceptable for study entry, but local IHC and FISH results for MYC must be available in order to determine if enrolling as DEL based on local results The diagnosis of DLBCL/HGBCL and assessment of DEL/DHL will be performed per standardized guidelines at local institutions and patients will be enrolled based on local determination. Given the heterogeneity in diagnostic work-up and interpretation, all local determinations will be followed by central confirmation in real time. Diagnostic slides and stains (or recuts/blocks) from all cases will be submitted to a central reference laboratory (Cleveland Clinic Laboratories). Immunostains will be reviewed or repeated (if unavailable or technically unsatisfactory) to confirm double expressing (DE) status. All DE cases will also be investigated for double hit (DH) status, if not already performed. To DHL status, FISH for translocations of MYC (break apart and IGH/MYC dual fusion probes) must be performed (either by referring site or at the central laboratory), along with BCL2 (break apart probes) and BCL6 (break apart probes). Any missing information from the referring site will be supplemented by the central lab on required submitted unstained slides or blocks. Cases submitted as DHL will be accepted as such upon review of submitted laboratory reports. Cases submitted as DHL must demonstrate the presence of a MYC translocation as well as a translocation of BCL2, BCL6, or both. Cases submitted as a DEL must demonstrate appropriate IHC protein expression of MYC and BCL2, and be negative for a MYC translocation by FISH No prior treatment for DLBCL/HGBCL is allowed with the exception of corticosteroids administered for palliation, or a single cycle of either rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or dose adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) administered prior to enrollment. Corticosteroids or local radiation therapy are also allowed. Patients may have received intrathecal chemotherapy for CNS prophylaxis prior to registration. This single pre-registration cycle is being allowed to facilitate enrolling patients who required immediate initiation of therapy for rapidly progressing disease, or for patients where FISH or IHC results returned after initiation of chemotherapy rendered them protocol eligible. Patients with DLBCL or HGBCL transformed from an underlying indolent lymphoma cannot have received prior chemotherapy, but prior anti-CD20 monoclonal antibody therapy or radiation therapy for an indolent B-cell lymphoma is allowed Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 25.0-90.0, Dementia With Lewy Bodies Written informed consent 2. Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR) 3. Age of 25-90 years, medically stable 4. Clinical diagnosis of DLB according to McKeith et al (https://www.ncbi.nlm.nih.gov/pubmed/28592453) with both dementia MoCA≥14 and Parkinsonian defined as bradykinesia in combination with rest tremor, rigidity or both UPDRS I-III ≤ 50 and UPDRS-III between 20-40. 5. Dementia and Parkinsonism must be present with at least one other symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD) 6. Stable on Levodopa no more than 800mg daily, acetylcholinesterase inhibitors, dopamine agonists for at least 6 weeks 7. Stable on monoamine oxidase inhibitors (MOA-B) for at least 4 weeks before enrollment and during the trial 8. Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI 9. Corrected QT interval (QTc) 350-470 ms, inclusive 10. Participants must be willing to undergo Lumbar puncture (LP) at baseline and 3 months after treatment Medical history of liver or pancreatic disease, GI ulcers and Chron's disease, kidney, GI, or blood problems 2. Abnormal liver function defined as Aspartate aminotransferase ( AST) and/or Alanine aminotransferase (ALT) > 100% the upper limit of the normal 3. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal or proteinuria 4. History of Human immunodeficiency virus (HIV), clinically significant chronic hepatitis, or other active infection 5. Hypokalemia, hypomagnesaemia, or long QT syndrome QTc≥471 ms or concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease, including myocardial infarction or cardiac failure, angina, arrhythmia 6. History or presence of significant cardiac conditions including: cardiovascular or cerebrovascular event (e.g. myocardial infarction, unstable angina, or stroke), congestive heart failure, first, second or third-degree atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances, any history of Torsade de Pointes. 7. Treatment with any of the following drugs at the time of screening or the preceding 30 days, and/or planned use over the course of the trial: Treatment with Class IA or III antiarrhythmic drugs (e.g. quinidine), treatment with QT prolonging drugs (www.crediblemeds.org) excluding SSRIs (e.g. Citalopram, Escitalopram, Paroxetine, Sertraline, Duloxetine, Trazodone, etc.). Should treatment with any of these agents be required, therapy with K0706 should be interrupted. 8. Females must not be lactating, pregnant or with possible pregnancy 9. Clinical signs indicating syndromes other than DLB including, AD idiopathic PD, corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, Babinski sign 10. Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or Diagnostic and Statistical Manual of Mental Disorders 4th Edition ( DSM-IV) for any active major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse 11. Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratory abnormality. 12. Active neoplastic disease, history of cancer five years prior to screening, including breast cancer (history of skin melanoma or stable prostate cancer are not exclusionary) 13. Contraindications to LP: prior lumbosacral spine surgery, severe degenerative joint disease or deformity of the spine, platelets < 100,000, use of Coumadin/warfarin, or history of a bleeding disorder. 14. Must not be on any immunosuppressant medications 15. Must not be enrolled as an active participant in another clinical study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Diffuse Large B-Cell Lymphoma Non Hodgkin's Lymphoma DLBCL NHL Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included DLBCL, NOS, Activated B-cell type (ABC) DLBCL, NOS, Germinal center B-cell type (GCB) T-cell/histiocyte-rich large B-cell lymphoma Primary cutaneous DLBCL, leg-type EBV+ DLBCL, NOS DLBCL associated with chronic inflammation ALK+ large B-cell lymphoma High-grade B-cell lymphoma, NOS High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements 2. A formalin-fixed tissue block or 15 slide of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. Patients must be willing to have a tumor biopsy if adequate archival tissue is not available (i.e., post-enrollment and prior to treatment). 3. Measurable lymph nodes or masses of at least 1.5 centimeters (cm) on baseline CT or MRI 4. Stage II, III, or IV disease as classified by the Ann Arbor Classification 5. Age greater than or equal to 18 years NOTE: Because no dosing or adverse event data are currently available on the use of acalabrutinib in patients <18 years of age, children are excluded. 6. ECOG performance status less than or equal to 2. 7. Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator Patients who meet histologic for the following subtypes are excluded Primary DLBCL of the central nervous system (PCNSL) Primary mediastinal B-cell lymphoma (PMBL) Plasmablastic lymphoma Intravascular large B-cell lymphoma B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma 2. Patients who, at the discretion of the investigator, need immediate cytoreductive chemotherapy such as patients with evidence of spontaneous tumor lysis or impending organ compromise are not eligible. 3. Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (<7 days) for acute issues prior to study enrollment are permitted. 4. Major surgical procedure within 28 days of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug 5. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study 6. Requires treatment with moderate or strong CYP3A inhibitors or inducers 7. Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, or chronic lymphocytic leukemia/small lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are excluded NOTE: Patients with evidence of small monoclonal B-cell clones isolated to the bone marrow or peripheral blood that meet for monoclonal B-cell lymphocytosis are not excluded 8. Known lymphomatous involvement of the CNS 9. Pregnant women, or women who intend to become pregnant during the study are excluded from this study because of potential teratogenic effects associated with acalabrutinib, R-CHOP, and/or DA-EPOCH-R 10. The potential for all study treatments to be excreted in breast milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, breastfeeding must be discontinued. 11. Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator Uncontrolled active systemic infection Any condition that requires anticoagulation with warfarin or equivalent vitamin K antagonist Active bleeding, history of bleeding diathesis (e.g., hemophilia or von Willebrand disease) Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-130.0, Chronic Lymphocytic Leukemia Men and women ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) 2. Diagnosis of CLL that meets published diagnostic (Hallek et al. 2018): 1. Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing ≥1 B-cell marker (CD19, CD20, and CD23) and CD5 2. Prolymphocytes may comprise <55% of blood lymphocytes 3. Presence of ≥5 × 109 B lymphocytes/L (5000/μL) in the peripheral blood (at any point since the initial diagnosis) 3. Active disease as per at least 1 of the following IWCLL 2018 1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin <10 g/dL) and/or thrombocytopenia (platelets <100,000/μL). 2. Massive (i.e., ≥6 cm below the left costal margin), progressive, or symptomatic splenomegaly. 3. Massive nodes (i.e., ≥10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy 4. Progressive lymphocytosis with an increase of >50% over a 2-month period or a lymphocyte doubling time (LDT) of <6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte count obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of <30x109/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infections) should be excluded. 5. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy 6. B-symptoms documented in the subject's chart with supportive objective measures, as appropriate, defined as ≥1 of the following disease-related symptoms or signs: o Unintentional weight loss ≥10% within the previous 6 months before screening o Significant fatigue (Eastern Cooperative Oncology Group [ECOG] performance status ≥2; inability to work or perform usual activities) o Fevers higher than 100.5°F or 38.0°C for ≥2 weeks before screening without evidence of infection o- Night sweats for ≥1 month before screening without evidence of infection 4. Must meet 1 of the following a. Have received no prior therapy for treatment of CLL and meets 1 of the following i. A score of >6 on the Cumulative Illness Rating Scale (CIRS) ii. Creatinine clearance of 30 to 69 mL/min using the Cockcroft-Gault equation b. Have previously received therapy for CLL and have either refractory or relapsed CLL c. Have received prior BTKi therapy (i.e., defined as a subject who discontinued a BTKi for any reason except disease progression) for CLL d. Criterion deleted. 5. ECOG performance status of ≤2 6. Female subjects of childbearing potential (i.e., not surgically sterile or postmenopausal) who are sexually active with a non-sterilized male partner must use ≥1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 2 days after the last dose of study treatment. Contraception measures and restrictions on sperm donation are not required for male subjects. 7. Fluorescence in situ hybridization (FISH) within 60 days before or during screening reflecting the presence or absence of del(17p), 13q del, 11q del, and trisomy of chromosome 12 along with the percentage of cells with the deletion, along with TP53 sequencing. Subjects must also have molecular analysis to detect IGHV mutation status at any time point since diagnosis. 8. Each subject (or legally authorized representative if allowed per local regulations) must be willing and able to adhere to the study visit schedule, understand and comply with other protocol requirements, and provide written informed consent and authorization to use protected health information Subjects who have had disease progression while on a BTKi for any malignant or nonmalignant condition 2. Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, early stage prostate cancer, or other cancer from which the subject has been disease-free for ≥2 years 3. History of confirmed progressive multifocal leukoencephalopathy 4. Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months before screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval using Fridericia's formula (QTcF) >480 msec at screening. Note: Subjects with rate-controlled, asymptomatic atrial fibrillation are allowed to enroll in the study. 5. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. 6. Evidence of active Richter's transformation. If Richter's transformation is suspected (i.e., lactate dehydrogenase [LDH] increased, asymmetric fast lymph node growth or clinical suspicion), it should be ruled out with positron emission tomographycomputed tomography (PET-CT) and/or biopsy according to guidelines. 7. Central nervous system (CNS) involvement by CLL. 8. Known history of human immunodeficiency virus, serologic status reflecting active hepatitis B virus or hepatitis C virus infection, any uncontrolled active systemic infection along with subjects who are on ongoing anti-infective treatment and subjects who have received vaccination with a live attenuated vaccine within 4 weeks before the first dose of study treatment. 1. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antibody (anti-HBs) negative will need to have a negative hepatitis B virus PCR result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B virus PCR positive will be excluded. 2. Subjects who are hepatitis C virus antibody positive will need to have a negative hepatitis C virus PCR result before enroll.lment. Those who are hepatitis C virus PCR positive will be excluded 9. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (>20 mg daily of prednisone or equivalent for longer than 2 weeks). 10. History of stroke or intracranial hemorrhage within 6 months before the first dose of study treatment. 11. History of bleeding diathesis (e.g., hemophilia or von Willebrand disease) 12. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. 13. Major surgical procedure within 4 weeks before first dose of study treatment. Note: Subjects who have had major surgery must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study treatment. 14. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 15. All subjects requiring or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days before first dose of study treatment. 16. Absolute neutrophil count (ANC) <0.50 x 109/L or platelet count <30 x 109/L, unless proven due to CLL and raised above the limits by granulocyte colony-stimulating factor (G-CSF) therapy and/or pooled platelet transfusion 17. Total bilirubin >3.0x upper limit of normal (ULN); or aspartate aminotransferase or alanine aminotransferase >3.0x ULN. Exception will be for Gilbert syndrome; if an investigator feels that a subject's total bilirubin is elevated secondary to Gilbert's, the subject must have a documented unconjugated bilirubin being >80% of the total bilirubin number. The investigator must also document that hemolysis has been ruled out along with (near)-normal lactate dehydrogenase and haptoglobin 18. Estimated creatinine clearance of <30 mL/min, calculated using the formula of Cockcroft and Gault or by direct assessment (i.e., creatinine clearance or ethylene diamine tetra-acetic acid (EDTA) clearance measurement) 19. Breastfeeding or pregnant 20. Received any chemotherapy, external beam radiation, investigational drug, or any other anti-CLL therapy within 30 days before first dose of study treatment 21. Concurrent participation in another therapeutic clinical study 22. History of interstitial lung disease 23. Requiring long-term (> 1 week) treatment with a strong cytochrome CYP3A inhibitor/inducer. In addition, the use of strong or moderate CYP3A inhibitors or inducers within 7 days of the first dose of study drug is prohibited | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.5-75.0, B-cell Leukemia Age older than 6 months. 2. Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy. 3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR. 4. The KPS score over 80 points, and survival time is more than 1 month. 5. Greater than Hgb 80 g/L. 6. No contraindications to blood cell collection Complications with other active diseases, and difficult to assess patient response. 2. Bacteria, fungus, or virus infection, and unable to control. 3. Living with HIV. 4. Active HBV and HCV infection. 5. Pregnant and nursing mothers. 6. Under systemic steroid use within a week of the treatment | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Asthma Female or male > 18 years and living in a Philadelphia neighborhood in which at least 20% of households have incomes below the federal poverty level (19104, 19120, 19121, 19122, 19124, 19125, 19131, 19132, 19133, 19134, 19139, 19140, 19141, 19142, 19143, 19144, 19145, 19146, 19153, 19151) A patient in a participating clinic Doctor's diagnosis of asthma Prescribed an inhaled corticosteroid for asthma Required prednisone or an Emergency Department (ED) visit or hospitalization for asthma within 12 months before enrollment Some patients with a diagnosis of asthma and prescribed inhaled corticosteroid may also have mention of Chronic Obstructive Pulmonary Disease (COPD) in their record, particularly if they smoke. Asthma and COPD are both heterogeneous diseases, and may be impossible to distinguish by clinical characteristics.Both COPD and asthma can have evidence of reversible obstruction and also of irreversible obstruction. It is important not to these patients, sometimes called overlap patients as they may benefit from these interventions Severe psychiatric or cognitive problems making it impossible to understand or carry out the protocol Excluded are those with other chronic lung diseases: lung cancer, cystic fibrosis, heart failure, chronic bronchitis, pulmonary hypertension, a candidate or recipient for lung transplant, a history of bronchial thermoplasty. Excluded are those with more than 20 pack year tobacco use | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-69.0, HCC HBV Coinfection older than 18 years and less than 69 years old; 2. HBsAg positive HCV antibody negative and HIV antibody negative; 3. HBV-DNA>200 IU/mL; 4. BCLC（Barcelona Clinic Liver Cancer） staging O and A stage; 5. Platelet100×10^9/L; 6. Liver function Child-Pugh A,with no invasion in portal vein, hepatic vein and two large branches, no extrahepatic metastasis; 7. Creatinine clearance rate≥ 70 mL/min; 8. Antiviral treatment was not performed before surgery or antiviral treatment was accepted in a short term (<3 months); 9. No treatment was performed before the operation. The results of postoperatively histopathological biopsy were HCC; 10. The patients agree to participate in the clinical trial The image found extrahepatic lymph nodes or visceral metastasis, the existence of large vascular invasion, the existence of bile duct embolus in the first operation; 2. The patient combined with a malignant tumor of other organs or had a history of other malignant tumors in other organs; 3. Liver function decompensation, such as: upper gastrointestinal bleeding, refractory ascites, coagulation dysfunction and so on; 4. contraindications to surgery; 5. Patients with poor compliance and not adhered to the follow-ups; 6. Patients refused to participate in the clinical trial | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-70.0, Malignant Pleural Effusion • All adult patients aged between18 years presenting with pleural effusion in association with a malignant disease Patients with documented malignant pleural effusion ( i.e positive pleural fluid for malignant cells on pleural fluid cytology and/or positive pleural biopsy for malignant tissue) Reaccumulation of an effusion after drainage or patients presenting with symptoms related to pleural fluid re-accumulation such as dyspnea, cough and chest pain Patient with full lung re-expansion after thoracostomy tube insertion and drainage of effusion • Patients with known hypersensitivity either to Povidone-iodine and/or Tetracycline Failure to achieve full lung re-expansion following drainage of the effusion within 48hrs Locoregional radiotherapy to the effusion side Loculated pleural effusion Refusal to participate in the study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Patient is at least 18 years old 2. Patient has an aortic valve vitium and requires an aortic valve replacement with the Edwards Aortic Valve™ 3. Patient is scheduled to attend yearly follow-up visits at the registry center up to 5 years 4. Patient provides written informed consent prior to the procedure and in case of emergency after the procedure Disability and / or other circumstances under which the patient is not capable to understand the nature, significance and scope of the clinical trial 2. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery 3. Patient has a life expectancy ≤ 12 months for any reason 4. Valve implantation is not possible in accordance with the device IFU 5. Pregnancy | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Stroke Headache Vertigo Meningitis/Encephalitis Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache. 2. Neurological examination results and imaging changes within 24 hours of admission Patients discharged, transferred to the hospital, or died within 24 hours after admission | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, Acute Cholecystitis • Clinically and radiologically confirmed acute cholecystitis Contraindication for MRCP Patients refuses MRCP | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, Lymphoma patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment leukemia | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Mantle Cell Lymphoma Peripheral T-cell Lymphoma (PTCL) Cutaneous T-cell Lymphoma (CTCL) Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) Follicular Lymphoma Marginal Zone Lymphoma Hodgkin Lymphoma Waldenstrom Macroglobulinemia DLBCL Adults ≥18 years of age 2. Patient has a life expectancy ≥ 3 month 3. Patient has relapsed or refractory disease Relapsed lymphoma: Relapsed lymphoma is disease that has responded to treatment but then returns. Refractory lymphoma: Failure to achieve complete response at the end of therapy or progression within 6 months from completion of therapy 4. Included Diseases DLBCL, including transformed lymphoma Mantle Cell Lymphoma PTCL CTCL CLL/SLL Follicular lymphoma Marginal zone lymphoma Hodgkin lymphoma (both classical and lymphocyte predominant) Waldenströms Macroglobulinemia 5. Must has failed or is not a candidate for available therapies with reasonable likelihood of clinical benefit, which includes FDA approved products and standard of care regimens 6. Therapy means at least three front lines of therapy including Hematopoeitic Stem Cell Transplant (HSCT and/or Chimeric Antigen Receptor (CAR) T cells, when applicable 7. Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study 8. Males must agree to use an adequate method of contraception during the study 9. Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2 10. Adequate hepatic and renal functions as defined by Active non-hematologic malignancy other than lymphoid malignancies treated with immuno or chemotherapy within the previous 12 months except active non-melanoma, non-invasive skin cancer will be allowed 2. Known, active Central Nervous System (CNS) involvement of disease requiring intrathecal therapy. Note: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening 3. Patient eligible for high dose chemotherapy and autologous stem cell transplant 4. Indolent non-Hodgkin lymphoma (iNHL) 5. Patients at high risk of Tumor Lysis Syndrome (TLS) a. Bulky disease i. A unidimensional lesion greater than 10 cm and/or b. Lymphocyte count greater than 25,000 per µL 6. Receipt of any anti-cancer therapy within 14 days prior to Cycle 1 Day 1 (C1D1) 7. Uncontrolled active, untreated, or progressive infection 8. Receipt of any investigational agent or on study treatment within 30 days prior to C1D1 9. Females who are pregnant, test positive for pregnancy, or are breast-feeding during the Screening period, or intend to become pregnant or breast-feed during the course of the study or within 30 days after last dose of study drug 10. Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study 11. Active hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitis C infection (based on Hepatitis C Virus (HCV) positive antibody [HCV Ab]), or human immunodeficiency virus (HIV-1 or HIV-2, based on positive antibody) 12. Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline EKG abnormality (e.g., QTcF >470 msec) 13. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack 14. Uncontrolled seizure disorder 15. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Cryptococcal Meningitis HIV/AIDS Clinical diagnosis of HIV infection; 2. newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF); 3. Anti-viral treatment naïve patients 4. anti-fungal treatment naïve patients hepatitis virus co-infection; 2. liver cirrhosis; 3. congestive heart failure; 4. chronic renal disorders; 5. chronic obstructive pulmonary disease (COPD); 6. Tuberculosis co-infection; 7. malignances 8. severe mental and neurological diseases 9. Women during pregnancy and lactation 10. intraveneous drug user (IDU) 11. patients with follow abnormal test results:hemoglobin < 6 g/dl, white blood cell count < 2000 / μl, neutrophil count < 1000 / μl, platelet count < 75000 / μl, blood amylase > 3 times normal level Upper limit, serum creatinine > 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase > 3 times normal upper limit, total bilirubin > 2 times normal upper limit 12. patients who are unwilling to anticipate | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Postpartum Depression Anxiety Age 18+ (at birth) Ability to speak English or French Livebirth Access to the internet and email (at step 2) Score on either EPDS 10 or GAD-7 of 10+. Women with a GAD-7 score of 15+ will be referred to the mental health nurse and will be included in the study Baby at home Women currently undergoing psychological treatment and /or having a history of bipolar disorder or psychosis will be excluded Severe symptoms (Score of 20 or more on the EPDS, will be excluded Any anti-depressant and/or psychological treatment will be managed by the participant's own physician and not by the research team | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma, Non-Hodgkin Each participant must meet all the following to be enrolled in the study: 1. Participant Population: o. For Phase 1 Dose Escalation: o. aNHL including mantle cell lymphoma and DLBCL histologies such as transformed DLBCL from low-grade lymphoma (follicular or others), DLBCL associated with small-cell infiltration in bone marrow, B-cell lymphoma with intermediate features between DLBCL and Burkitt's lymphoma or with intermediate features between DLBCL and Hodgkin lymphoma, FL grade 3B, and aggressive B-cell lymphoma unclassifiable who must have previously received rituximab, cyclophosphamide, doxorubicin (hydroxydaunorubicin), vincristine, (Oncovin) and prednisone (R-CHOP) (or equivalent anti-CD20 containing therapy) and 1 additional line of therapy in the r/r setting. o. iNHL (including FL of grades 1-3A and marginal zone lymphoma) refractory to rituximab or to any other anti-CD20 monoclonal antibodies, who have received at least 1 prior systemic therapy for r/r iNHL: o Rituximab or anti-CD20 refractoriness is defined as failure to respond to, or progression during, any previous rituximab/anti-CD20-containing regimen (monotherapy or combined with chemotherapy), or progression within 6 months of the last rituximab or anti-CD20 dose. Note: The minimum qualifying rituximab/anti-CD20 dose is 1 full cycle (that is, weekly*4 doses monotherapy or 1 complete dose if combined with chemotherapy). Prior anti-CD20 antibody or cytotoxic drugs may have been administered as single agents or as components of combination therapies. Each repeated course of the same single-agent or combination is considered an independent regimen. o. For Phase 2: o. r/r DLBCL progressed or relapsed after a prior CAR T-cells therapy that has received approval by a health authority for the treatment of DLBCL (Cohort A). o. r/r DLBCL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy and has not I prior cellular therapy. At least one prior line of therapy must have included a CD20-targeted therapy (Cohort B). o. r/r FL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy. At least one prior line of therapy must have included a CD20-targeted therapy (Cohort C). 2. Must be considered ineligible in the opinion of the investigator, or refused autologous stem-cell transplantation. 3. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (<=) 2. 4. Adequate bone marrow function per local laboratory reference range at screening as follows: o Platelet count greater than or equal to (>=) 75.0*10^9/L, Grade 2 thrombocytopenia (platelet count >=50.0*10^9 per liter [/L]) is allowed if it is clearly due to marrow involvement with no evidence of myelodysplastic syndrome or hypoplastic bone marrow if found. Absolute neutrophil count (ANC) >=1.0*10^9/L. Hemoglobin >=85 gram per liter (g/L) (red blood cell [RBC] transfusion allowed >=14 days before assessment). 5. Adequate renal and hepatic function, per local laboratory reference range at screening as follows Calculated creatinine clearance >=45 milliliter per minute (mL/min) calculated with Cockcroft-Gault formula Aspartate aminotransferase and alanine aminotransferase <=3.0*the upper limit of normal (ULN) of the institution's normal range; bilirubin <=1.5*ULN. Participants with Gilbert's syndrome may have a bilirubin level >1.5*ULN, per discussion between the investigator and the medical monitor. 6. Left ventricular ejection fraction (LVEF) >=40 percent (%); as measured by echocardiogram or multiple gated acquisition scan (MUGA). 7. Suitable venous access for safe drug administration and the study-required PK and pharmacodynamic sampling. 8. Have at least 1 bidimensionally measurable lesion per Lugano Classification (>1.5 centimeter [cm] in its largest dimension) by computed tomography (CT). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. In the Phase 2, Stage 1 portion of the study >1 measurable lesions are required, 1 for biopsy, and 1 for response. 9. Willing to consent to 1 mandatory pretreatment and 1 on-treatment skin biopsy during Phase 1. The skin biopsy entry requirement may be discontinued by the sponsor once there is enough pharmacodynamic evidence of target engagement. 10. For participants enrolled in Phase 2, Stage, willing to consent to one mandatory pretreatment and 1 on-treatment tumor biopsy. For fresh tumor biopsies, the lesion must be accessible for a low risk biopsy procedure (those occurring outside the brain, lung/mediastinum, and intra-abdominal, or obtained with endoscopic procedures beyond the stomach or bowel). The skin biopsy entry requirement may be discontinued by the sponsor once there is enough pharmacodynamic evidence of target engagement. Outside of Phase 2 Stage 1, paired tumor biopsies are optional. 11. Recovered to Grade 1, baseline or established as sequela, from all toxic effects of previous therapy (except alopecia, neuropathy, autoimmune endocrinopathies with stable endocrine replacement therapy, neurotoxicity [Grade 1 or 2 permitted], or bone marrow parameters [any of Grade 1, 2, permitted if directly related to bone marrow involvement]) Participants meeting any of the following are not to be enrolled in the study: 1. Central nervous system lymphoma; active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or CT scan/magnetic resonance imaging (MRI). 2. History of Grade >=3 infusion-related reaction (IRR) that lead to permanent discontinuation of previous rituximab treatment. 3. Post transplantation lymphoproliferative disease except relapsed NHL after autologous stem cell transplantation. 4. Undergone ASCT or treatment with cellular therapy including CAR T within <=3 months of TAK-981 dosing. 5. Prior allogeneic hematopoietic stem-cell transplantation. 6. Lymphomas with leukemic expression. 7. Prior anticancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 5 half-lives before TAK-981 dosing (up to a maximum of 4 weeks), whichever is shorter. Low dose steroids (oral prednisone or equivalent <=20 mg per day), hormonal therapy for prostate cancer or breast cancer (in adjuvant situation), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are allowed. 8. Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery. 9. Significant medical diseases or conditions, as assessed by the Investigators and Sponsor that would substantially increase the risk-benefit ratio of participating in the study. This includes but is not limited to acute myocardial infarction or unstable angina within the last 6 months, uncontrolled diabetes mellitus, significant active bacterial, viral or fungal infections, severely immunocompromised state, severe non-compensated hypertension and congestive heart failure New York Heart Association Class III or IV, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (example, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed. 10. Known chronic hepatitis C and/or positive serology (unless due to vaccination or passive immunization due to immunoglobulin (Ig) therapy) for chronic hepatitis B. Known Human Immunodeficiency Virus (HIV) infection. 11. Second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy. 12. Receipt of any live vaccine (example, varicella, pneumococcus) within 4 weeks of initiation of study treatment. 13. Active, uncontrolled autoimmune disease requiring >20 mg of prednisone or equivalent, cytotoxics or biologicals. 14. Corticosteroid use within 1 week before the first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. Participants requiring steroids at daily doses >20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for lymphoma control or white blood cell count lowering are not eligible. 15. With baseline prolongation of the Fridericia-corrected QT interval (QTc) (QT interval with Fridericia correction method (example, repeated demonstration of QTcT interval >480 millisecond (ms), history of congenital long QT syndrome, or torsades de pointes). 16. Receiving or requiring the continued use of medications that are known to be strong or moderate inhibitors and inducers of Cytochrome P450 3A4/5b (CYP3A4/5 b) and strong P-glycoprotein (Pgp) inhibitors. To participate in this study, such participants should discontinue use of such agents for at least 2 weeks (1 week washout for CYP3A4/5 inhibitors, and 2 weeks washout if using CYP3A4/5 inducers) before receiving a dose of TAK-981 | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 2.0-15.0, Encephalitis Meningitis Neurological sequelae due to encephalitis or meningitis Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, CLL Transformation Ability to understand and the willingness to sign a written informed consent document 2. Signed Informed Consent 3. Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as IW-CLL 2008 (Hallek et al, 2008) with biopsy proven transformation to diffuse large B cell lymphoma (DLBCL), consistent with Richter's Syndrome 4. Age greater than or equal to 18 years 5. ECOG performance status <= 2 6. Patients must meet the following hematologic at screening, unless they have significant bone marrow involvement of their malignancy confirmed on biopsy Absolute neutrophil count >=1000 cells/mm3 (1.0 x 10^9/L) Platelet count >= 50,000 cells/mm3 (50 x 10^9/L) within 7 days of screening Total hemoglobin > 9 g/dL (without transfusion support, unless anemia is due to marrow involvement of CLL) 7. Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at screening as follows Activated partial thromboplastin time (aPTT) and International normalized ratio (INR) > 1.5 x ULN for patients not receiving therapeutic anticoagulation Creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min based on Cockcroft-Gault formula Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN Bilirubin <= 1.5 × ULN; 8. Subjects with Gilbert's Syndrome or resolving autoimmunohemolytic anemia may have a bilirubin up to 3.0 × ULN and are still eligible 9. Negative pregnancy tests as verified by the investigator prior to starting any treatment Prior treatment for Richter transformation. 2. Prior treatment with obinutuzumab anti PD-1 or PDL-1 antibodies. 3. Prior treatment with venetoclax. 4. Hypersensitivity to obinutuzumab, venetoclax or atezolizumab or their formulation excipients. 5. Patients with the Hodgkin variant transformation of CLL. 6. Prolymphocytic transformation. 7. Patients with a previous history of indolent B cell malignancies other than CLL. 8. History of other malignancy other than CLL and Richter syndrome that could affect compliance with the protocol or interpretation of results with the exception of: 1. Patients with curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin or in situ carcinoma of the cervix 2. Patients with a malignancy that has been treated with surgery alone with curative intent. Individuals in documented remission without treatment for > 2 years prior to enrollment may be included at the discretion of the Sponsor-Investigator. 3. Low-risk prostate cancer on active surveillance. 9. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient, including renal disease that would preclude chemotherapy administration or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm). 10. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle1, Day1. 11. Clinically significant history of liver disease, including autoimmune hepatitis, current alcohol abuse, or cirrhosis. 12. Presence of positive PCR for hepatitis B, hepatitis C or positive hepatitis B surface antigen. 13. Patients with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia. 14. History of active autoimmune disease. 15. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest CT scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed. 16. Concurrent systemic immunosuppressant therapy within 28 days of the first dose of study drug. 17. Corticosteroids are allowed, but must be dosed at prednisone 30 mg (or equivalent) or lower prior to the start of chemotherapy. 18. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug. 19. Known bleeding disorders (eg, von Willebrand's disease) or hemophilia. 20. Requires anticoagulation with vitamin K antagonists (e.g. phenprocoumon, warfarin) 21. History of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or active hepatitis B virus (HBV). 22. Major surgery within 4 weeks of first dose of study drug. 23. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk. 24. Patients with infections requiring IV treatment (Grade 3 or 4) within the last 2 months prior to enrolment | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 25.0-999.0, Bariatric Surgery Candidate Bone Loss Postmenopausal women who are planning RYGB or SG surgery Men aged ≥ 50 years who are planning RYGB or SG surgery Prior bariatric surgery Weight = 400 lbs (due to limitations of bone imaging equipment) Renal disease Hypercalcemia or hypocalcemia Hypomagnesemia Serum 25-OH vitamin D (25OHD) < 20 ng/mL Hyperparathyroidism Liver disease (AST or ALT > 2 x upper normal limit) HCT < 32% History of malignancy (except basal cell carcinoma) in the past 1 year | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, DVT Non-pregnant females Adult patients (age 18 years and older) Referred to Interventional Radiology for IVC filter removal IVC filter implanted less than 6 months with the procedure being performed at UCMC by current IR staff Cook Celect filter or Argon Medical Option Elite Patients with outside hospital filter placement Filters other than Cook Celect or Argon Medical Option Elite Implantation period >6 months Evidence of coagulopathy (INR <1.8, platelet count >50k) Clotting disorder Central venous occlusion Prior filter placement/removal | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.083-18.0, Encephalitis, Viral Pediatric patients who attending Neurology unit in Assiut University Children Hospital and diagnosed as viral encephalitis Age 1month : 18 year Both sexes Diagnosis of viral encephalitis will be confirmed by clinical picture ,investigations and of other causes of encephalopathy Autoimmune encephalitis Renal failure (any patient with abnormal renal function tests will be excluded) Hepatic failure ( any patient with abnormal liver function tests will be excluded) Metabolic disorders (any patient with abnormal level of ammonia and lactate ) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma Central Nervous System Metastasis Pilot Study: 1. Verified or suspected primary CNS lymphoma or verified or suspected DLBCL relapsed in the CNS 2. Treatment of the relapse not initiated (except pretreatment with corticosteroids) 3. Age ≥ 18 years 4. Patient must consent to genetic and metabolomic analysis of their cancer 5. Written informed consent Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated 2. Other contraindications to lumbar puncture according to local guidelines 3. Other previous or current hematological malignancy 4. Prior treatment for CNS disease (except CNS prophylaxis in first line lymphoma treatment) 5. Known CNS autoimmune or inflammatory disease 6. Known HIV infection 7. Patient is currently receiving treatment for DLBCL Study 1 1. Previously diagnosed histologically documented DLBCL 2. Verified relapsed DLBCL 3. ≥ 1 prior DLBCL treatments 4. Treatment of the relapse not initiated (except pretreatment with corticosteroids) 5. Being able to undergo standard assessment ( eg, Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET), MRI of the neuroaxis and bone marrow biopsy) 6. Tumor biopsy and/or bone-marrow biopsy used for diagnosis available 7. Age ≥ 18 years 8. ECOG performance status of 0, 1 or 2 9. Life expectancy ≥ 12 weeks 10. Patient must consent to permit genetic and metabolomic analysis of their cancer 11. Patient must consent to permit access to records in order to ascertain progression or relapse of their cancer 12. Written informed consent Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated 2. Other contraindications to lumbar puncture according to local guidelines 3. Other previous or current hematological malignancy 4. Previous or current primary CNS malignancy including know DLBCL relapse to the CNS 5. Prior treatment for CNS disease (except CNS prophylaxis in first line lymphoma treatment) 6. Known CNS autoimmune or inflammatory disease 7. Known HIV infection 8. Patient is currently receiving treatment for DLBCL (except pretreatment with corticosteroids) Study 2 1. A newly diagnosed and histologically verified DLBCL 2. No prior DLBCL treatments 3. Anti-lymphoma treatment not initiated (except pretreatment with corticosteroids) 4. CNS-IPI >/= 3 5. Being able to undergo standard assessment ( eg, Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET), MRI of the neuroaxis and bone marrow biopsy) 6. Tumor biopsy and/or bone-marrow biopsy used for diagnosis available 7. Age ≥ 18 years 8. ECOG performance status of 0, 1 or 2 9. Life expectancy >/= 12 weeks 10. Patient must consent to permit genetic analysis of their cancer 11. Patient must consent to permit access to records in order to ascertain progression or relapse of their cancer 12. Written informed consent Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated 2. Other contraindications to lumbar puncture according to local guidelines 3. Other previous or current hematological malignancy 4. Previous or current primary CNS malignancy including primary CNS lymphoma 5. Prior treatment for CNS disease 6. Known CNS autoimmune or inflammatory disease 7. Known HIV infection 8. Patient is currently receiving treatment for DLBCL (except pretreatment with corticosteroids) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Hypertension Diabetes Obesity COPD CHF High Cholesterol Asthma Chronic Pain Multiple Sclerosis Depression Anxiety Heart Diseases Stroke At least 18 years old Diagnosed with at least one chronic health condition (as reported by the participant) Able to participate safely in all program sessions Proficient in English Cognitively able to consent to participate Severe visual or auditory impairment Severe and/or uncontrolled comorbidity precluding safe participation in the program | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-70.0, Dasatinib BCR-ABL Chronic Myeloid Leukemia Age ≥ 18 years Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months ECOG performance of 0-2 Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital History of any TKI treatments History of Pulmonary arterial hypertension and Pleural effusion NYHA cardiac class 3-4 heart disease Cardiac symptoms Patients meeting the following are not eligible unless cleared by a cardiologist Uncontrolled angina within 12 months Diagnosed or suspected congenital long QT syndrome Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes) Prolonged QTc interval on pre-entry electrocardiogram (>450 msec) Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-120.0, Acute Cholecystitis Endothelial Dysfunction Patients undergoing acute or subacute cholecystectomy due to acute cholecystitis with a maximum of 7 days of symptoms prior to surgery Not capable of giving informed consent after oral and written information Surgery within 30 days of study Conditions that prevent the performance of remote ischemic preconditioning on the upper extremity, e.g. fractures, paresis, lymphedema performance of concomitant endoscopic retrograde cholangiopancreatography (ERCP) during surgery synchronous pancreatitis synchronous cholangitis | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma, B-Cell Lymphoma, Non-hodgkins Chronic Lymphocytic Leukemia B-Cell Chronic Lymphocytic Leukemia Patients must have any B-cell lymphoma, or CLL/SLL, Gray-zone lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma, or classical Hodgkin lymphoma with any CD19 or CD20 expression on Reed-Sternberg cells. Lower grade lymphomas or CLL transformed to DLBCL are potentially eligible as is primary mediastinal B-cell lymphoma and all other subtypes of DLBCL. Burkitt and mantle cell lymphoma are potentially eligible For classical Hodgkin lymphoma only, a biopsy from any time from any institution that shows any CD19 or CD20 expression on Reed-Sternberg cells is adequate for eligibility. CD19 or CD20 expression on the Reed-Sternberg cells that is weak or only present on some Reed-Sternberg cells by immunohistochemistry is compatible with protocol eligibility For all lymphoma types except for classical Hodgkin lymphoma, either CD19 or CD20 expression must be uniform . Uniform CD19 or CD20 expression is defined as no obvious lymphoma population lacking antigen expression is present. Antigen expression can be assessed by either immunohistochemistry or flow cytometry Only when insufficient biopsy material is available to allow CD19 and CD20 expression assessment at the NIH, CD19 and/or CD20 staining performed at another institution can be used DLBCL patients must have received at least two prior chemotherapy-containing regimens at least one of which must have contained doxorubicin and a monoclonal antibody. Follicular lymphoma patients must have received at least 2 prior regimens including at least 1 regimen with chemotherapy. All other B-cell lymphoma and leukemia patients must have had at least 1 prior chemotherapy-containing regimen. All patients with CLL or small lymphocytic lymphoma must have had prior treatment with ibrutinib or another signal transduction inhibitor.and venetoclax Hodgkin lymphoma patients must have had at least 3 prior lines of therapy documented progression of lymphoma while on checkpoint inhibitor therapy or failure to respond to checkpoint inhibitor therapy, or intolerance to checkpoint inhibitor therapy had at least 1 prior cytotoxic chemotherapy-containing regimen had prior exposure to brentuximab vedotin Patients that require urgent therapy due to tumor mass effects or spinal cord compression Patients must not have received any anti-CD20 or anti-CD19 antibody products in the past 30 days prior to CAR T-cell infusion Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with infusion of CAR-T cells within 8 weeks of enrollment Patients that have active hemolytic anemia HIV-positive patients are excluded because HIV causes complicated immune deficiency and study treatment can pose more risks for these patients Patients with second malignancies in addition to their B-cell malignancy are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 3 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Pregnant women are excluded from this study because study therapy can cause fetal harm. Because there is potential risk for adverse events in nursing infants secondary to treatment of the mother with study therapy, breastfeeding should be discontinued if the mother is treated with study drugs Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of ventricular tachycardia or ventricular fibrillation, active cardiac arrhythmias (active atrial fibrillation is not allowed, resolved atrial fibrillation not requiring current treatment is allowed (anticoagulants count as current treatment) ), active obstructive or restrictive pulmonary disease, active autoimmune diseases such as rheumatoid arthritis Hospitalization within the 7 days prior to enrollment Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-70.0, B Acute Lymphoblastic Leukemia Mantle Cell Lymphoma Follicular Lymphoma At the time of initial diagnosis, the age is 18-70 years old, regardless of gender or race Morphological analysis showed that the load of lymphoma was ≥ 5% Estimated survival time > 12 weeks The main investigator and the attending physician of the patient think that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation Relapsed / refractory B-cell acute lymphocytic leukemia (all): A. objective remission rate (or) of grade 2 or higher bone marrow recurrence B. bone marrow relapse after allogeneic stem cell transplantation (SCT), SCT treatment is more than 6 months and in or state before cart-19 reinfusion C. refractory patients (CR status is not reached after 2 rounds of standard chemotherapy (CR refers to the load of myeloma detected by morphology < 5%)) D. Philadelphia chromosome positive (Ph +) and tyrosine kinase inhibitor (TKI) treatment failed twice or TKI failed to maintain or E. treatment with allogeneic SCT For patients with relapse, CD19 was detected in bone marrow or peripheral blood by flow cytometry within 3 months before admission CD19 expression on lymphoma cells: immunohistochemistry > 15% or flow cytometry > 30% The main organ functions are sound, including: A. renal function: radioisotope glomerular filtration rate > 60 ml / min / 1.73 m2, or serum creatinine clearance rate in line with relevant age / gender standards B. alanine transferase (ALT) < 5 times the normal maximum value of the same age C. bilirubin < 2.0 mg / dl D. to achieve the minimum pulmonary function: ≤ grade I dyspnea and indoor blood oxygen concentration > 91% E. echocardiography or multi gated angiography (MUGA) showed that the left ventricular short axis shortening rate (LVSF) was ≥ 28%, or left ventricular ejection fraction (LVEF) was ≥ 45% Karnofsky score (age ≥ 16 years old) ≥ 50 or zubrod-ecog-who score ≤ 2 Sign written informed consent and obtain consent before any research is carried out Recurrence of isolated extramedullary diseases The patient is accompanied by the following genetic syndrome: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known myelofailure syndrome. Patients with Down syndrome are not included in the Patients with Burkitt's lymphoma / leukemia (i.e. patients with mature B cell all, B cell surface immunoglobulin positive (SIG +) and light chain kappa or lambda type, morphology Fab L3 or myc ectopic expression) Patients with previous history of malignant tumor but cured skin or cervical carcinoma in situ and patients with inactive tumor are not included in the Previous use of gene therapy Previous use of anti-CD19 / CD3 combination therapy or any other anti-CD19 treatment Hepatitis B or C or HBV / HCV or other uncontrolled infection at the time of screening Screening with HIV infection Acute or chronic graft-versus-host reaction (GVHD) of level 2-4 Use the following drugs: A. steroid: it is forbidden to use within 72 hours before cart-19 reinfusion, but physiological steroid treatment dose (< 6 | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Non Hodgkin Lymphoma (NHL) Mantle Cell Lymphoma (MCL) FOR ALL 1. Patients must be aged ≥18 years with relapsed or refractory B-cell non-Hodgkin Lymphoma. 2. Absolute cluster of differentiation 3 (CD3) count ≥50 mm3. 3. Magnetic resonance imaging (MRI) brain and Lumbar Puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment. 4. Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 20 mm in the long axis or extranodal lesions >10 mm in long and short axis OR bone marrow involvement that is biopsy proven. 5. Karnofsky performance score ≥60. 6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease. 7. Adequate renal function, defined as creatinine clearance>40 ml/min. 8. Able to provide written informed consent. 9. Agree to practice birth control during the study. 10. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥35% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%. 11. Expected survival >12 weeks. 12. Negative urine or serum pregnancy test in females of child bearing potential at study entry. 13. Meet for regarding fertility and contraception. 14. No contraindication to central line access. Phase 1: 3+3 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, and Diffuse large B-cell lymphoma (DLBCL) with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following criteria. 1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant 3. Relapse post-allogeneic transplant 4. Patients not previously treated with CAR-T cell therapy PHASE 1b and 2 1: 6-9 patient expansion with 8-day manufacturing (Phase 1b) 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following 1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant. 3. Relapse post-allogeneic transplant. 4. Relapse post-anti-cluster of differentiation 19 (CD19) CAR-T cell therapy. i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort. 2: 6-9 patient expansion with 12-day manufacturing (Phase 1b) 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following 1. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant. 3. Relapse post-allogeneic transplant. 4. Relapse post-anti-CD19 CAR-T cell therapy. i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort. 3: Mantle Cell Lymphoma (Phase 2) 1. Diagnosis of Mantle Cell Lymphoma. 2. Patients must have active, measurable disease as previously designed and have relapsed, refractory disease as defined as one of the following: 1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody. 2. Progressive disease after ≥second line Bruton tyrosine kinase (BTK) inhibitor. 3. Relapse post-autologous transplant. 4. Relapse post-allogeneic transplant. 5. Relapse post anti-CD19 CAR-T cell therapy. i. A maximum of four patients with history of prior anti-CD19 CAR-T will be allowed in this cohort (all patients) A potential subject who meets any of the following is ineligible to participate in the study. 1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per table 1. 2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection. 3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as >20 mg of prednisone or equivalent daily. 4. Presence of ≥grade 3 non-hematologic toxicities as per Common Terminology for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease. 5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis. 6. Refusal to participate in the long-term follow-up protocol. 7. Patients with active CNS involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. a. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis. 8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are <100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression. 9. Previous recipients of CAR-T cell therapy directed at either CD19 or CD20 are excluded if they are <100 days post prior CAR-T cell treatment (does not re-enrollment). a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry. 10. Anti-CD20 antibody treatment within 4 weeks of cell infusion. 11. Anti-CD19 antibody treatment within 4 weeks of cell infusion. 12. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion (corticosteroids or targeted therapies for bridging allowable e.g. venetoclax, BTK inhibitors, lenalidomide, etc). 13. Cytotoxic chemotherapy treatment within 10 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells. 14. Patients post solid organ transplant who develop high grade lymphomas or leukemias. 15. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 21.0-70.0, Obesity Morbid Obesity Weight Loss Male or female, aged ≥21 and ≤70 years Willing, able, and mentally competent to provide written informed consent Obese patients with a BMI ≥35 kg/m2 Weight ≤400 lb Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist is amendable to bariatric embolization, as assessed via 3D CT angiography Suitable for protocol therapy, as determined by the interventional radiology investigator Adequate hematologic (neutrophils>1.5x109/L, platelets>70x109/L, international normalized ratio (INR<1.5), hepatic (bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated glomerular filtration rate (GFR)>60milliliter mL/min. 1.73m2) function For females of reproductive potential: agreement to use of highly effective contraception for duration of study participation Patients who have failed conservative weight loss therapies such as supervised low calorie diets combined with behavior therapy and exercise hemoglobin A1c greater than 8% Patients who are currently taking either Insulin or sulfonylurea (medication changes are allowed) Prior history of gastric, pancreatic, hepatic, and/or splenic surgery Prior radiation therapy to the upper abdomen Prior embolization to the stomach, spleen, or liver Cirrhosis Known portal venous hypertension Active peptic ulcer disease Significant risk factors for peptic ulcer disease, including daily NSAID use Large hiatal hernia, defined as >5 cm in size | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Acute Cholecystitis Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included Pregnancy Patients unwilling to undergo follow-up assessments Patients with suspected gangrene or perforation of the gallbladder Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal) Patients with duodenal obstruction Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum Patients with liver cirrhosis, portal hypertension and/or gastric varices Abnormal coagulation: international normalised ratio (INR) > 1.5 and/or platelets < 50.000/mm3 Previous drainage of the gallbladder | 0 |
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