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This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 50.0-75.0, Osteoporosis Prostate Cancer Biopsy-confirmed early stage prostate cancer Disease localized within the capsule No evidence of regional or distant spread (i.e., T1-2, N0, M0 disease) A cohort of patients must have undergone a prior radical prostatectomy Prostate specific antigen < 12 ng/mL Gleason score ≥ 6 Creatinine clearance ≤ 2.0 mg/dL No Paget's disease No hyperthyroidism or hypothyroidism No Cushing's disease | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Metastatic Colorectal Cancer Patients must have metastatic colorectal cancer. Patients are eligible whether they are previously untreated or had received prior treatment. 2. Patients must have a source of autologous tumor that can be easily harvested. This includes patients with subcutaneous or cutaneous metastases, patients with easily excisable lymph nodes containing metastatic tumor, and patients with malignant pleural effusions or ascites. In addition, some patients who undergo a planned curative operation are found at that time of surgery to be unresectable and these patients could have a sample of tumor resected at that time to be eligible for this study. 3. Karnofsky performance status equal to or greater than 70%. 4. Life expectancy of at least three months. 5. Patients must have evaluable or measurable disease in addition to the disease that will be surgically removed for the purposes of formulating the autologous vaccine. 6. Adequate baseline hematopoietic function: 1. platelet count equal to or greater than 100,000/mm3 2. total white blood count equal to or greater than 3,000/mm3 7. Patients must not have received any antineoplastic chemotherapy or immunotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin-C). 8. Patients must not have received irradiation for the four weeks prior to entry onto the study. 9. Ability to give informed consent Patients may not have received prior antitumor vaccines. 2. History of any autoimmune diseases (e.g. SLE, rheumatoid arthritis, myasthenia gravis). 3. Active infection (bacterial, fungal, or viral), or active bleeding (e.g. hemoptysis, GI bleeding). 4. Pregnancy or lactation; women of childbearing potential and men must use effective contraception during the course of this clinical trial. 5. Uncontrolled angina, arrhythmias, bronchospasm, hypertension, hyperglycemia or hypercalcemia. 6. History of corticosteroid use in the four weeks preceding entry onto the clinical study. 7. Patients who require corticosteroids. 8. Evidence of HIV infection or AIDS and/or testing positive for HBSAg. 9. Any medical or psychiatric illness which in the opinion of the clinical investigators would compromise the patients ability to tolerate this treatment. 10. Patients who require anticoagulation. 11. There is no for sex or ethnic background | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 16.0-70.0, Lymphoma Histologically confirmed follicular non-Hodgkin's lymphoma (NHL) High-risk disease, as defined by any of the following Relapsed within 6 months after the last treatment Failed to achieve a complete response during the last treatment Relapsed after prior autologous hematopoietic stem cell transplantation (HSCT) No current transformation of lymphoma (e.g., elements of intermediate or high-grade lymphoma by biopsy) No active CNS disease by lumbar puncture or radiology scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. Age to 70 Performance status Karnofsky 50-100% Life expectancy | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Patients with low grade NHL (follicular lymphoma, small cell lymphocytic lymphoma, marginal cell lymphoma, monocytoid B-cell lymphoma, MALT lymphoma, plasmacytoid lymphocytic lymphoma) or chronic lymphocytic leukemia who have demonstrated chemotherapy resistance (have not achieved CR,CRu, PR)or who have relapsed at any time following a response (CR, CRu, PR) after at least one therapy regimen, including chemotherapy, Rituximab, or high dose chemotherapy with stem cell rescue Karnofsky performance status 60 % or greater Creatinine less or equal to 2.0 mg/dl, bilirubin less or equal to 2.0 mg/dl, SGPT/SGOT less or equal to 4 x upper normal range Patients with unconfirmed complete response(CRu)after last treatment and who currently remain in CRu Pregnant or lactating women Disease-specific treatment less than 1 month prior to starting this study CNS disease HIV-positive patients Other cancer, except basal cell or squamous cell cancer of the skin or carcinoma in-situ of cervix | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, B-Chronic Lymphocytic Leukemia Diagnosis of B-CLL (no mantle cell) Must have active disease Age >=18 yo ECOG 0-3 No radiation or surgery <4 weeks Any of the following comorbid conditions New York Heart Association Class III or IV heart disease Recent myocardial infarction (<1 month) Uncontrolled infection Active infection with the human immunodeficiency virus (HIV/AIDS) as further severe immunosuppression with this regimen may occur Pregnant or nursing women Men or women of child bearing potential must use adequate contraception Active primary malignancy requiring treatment or limits survival to ≤2 years Any radiation therapy ≤4 weeks prior to study entry Any major surgery ≤4 weeks prior to study entry | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Lymphoma, B-Cell Relapsed or refractory B-Cell NHL Histological documentation of diffuse large B-cell lymphoma, follicular lymphoma (grade 1, 2, or 3), small lymphocytic lymphoma or transformed B-Cell lymphoma Bi-dimensionally measurable disease with at least one lymph node or tumor mass measuring > or equal to 4 cm2 ECOG performance status less than or equal to 2 Failure to respond or progression of disease after 2 or more prior treatment regimens; this may high dose therapy (HDT) with stem cell transplantation (SCT). Patients with prior HDT plus SCT will be considered as having "diminished bone marrow reserve" At least 18 years of age At least 3 weeks from last anti-lymphoma therapy Mild to moderate cytopenia defined as any of the following ANC > or equal to 1,000/microL and < 1,500/microL off growth factors WBC counts > or equal to 2,000/microL and < 4,000/microL off growth factors or Less than 6 months from prior allogeneic stem cell transplant and/or patient with active graft versus host disease (GVHD) Grade > or equal to 2 Prior history of veno-occlusive disease of the liver Inability to comply with protocol requirements of this study for intravenous administration of ONTAK Pregnant women or lactating women who are breastfeeding or women planning to become pregnant during the treatment period Serious intercurrent medical illnesses or active infections that, in the investigators opinion, might interfere with the interpretation of the study safety data or compromise the patients ability to carry out the treatment program Known history of seropositivity for HIV or chronic hepatitis (testing for HIV is not required) Known hypersensitivity to ONTAK or any of its components: diptheria toxin, interleukin-2 or excipients Experimental therapy within 4 weeks prior to study entry Patients diagnosed with congestive heart failure, NYHA Class III or IV, ventricular tachycardia, fibrillation, or a history of myocardial infarction in the 12 months prior to study entry Any prior radiation therapy within four weeks of enrollment, or prior radiation therapy to the only site of evaluable disease unless disease progression has occurred in that site | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 15.0-80.0, Leukemia, Lymphocytic, Chronic, B-Cell Patients with histologically or cytologically confirmed CLL Patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal Patients who have not received cancer chemotherapy or radiotherapy Patients with apparent infections (including viral infections) Patients with serious complications (heart, liver, or kidney disease, etc.) Patients with a serious bleeding tendency (e.g., DIC) Patients with serious CNS symptoms Patients with fever >= 38°C (excluding tumor fever) Patients with interstitial pneumonia or pulmonary fibrosis Patients with active multiple cancers Patients receiving other investigational products within 6 months before registration in this study Patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives) Women who are pregnant, of childbearing potential, or lactating | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia B-cell Leukemia Chronic Leukemia Chronic Lymphocytic Leukemia (CLL) ≥ age 18 Karnofsky performance status 60% or above Confirmed immunohistological diagnosis of Chronic Lymphocytic Leukemia (CLL) Rai Stage I to IV as follows Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk) Patients with Rai Stage I II or (Modified Rai Intermediate-Risk) disease must have an indication for therapy based on 1996 NCI revised for active disease as follows Any one of the following disease-related symptoms: 1. Weight loss ≥ 10% body weight within the previous 6 months 2. Extreme fatigue 3. Fever greater than 100.5° F for ≥ 2 weeks without evidence of infection 4. Night sweats without evidence of infection Evidence of progressive marrow failure based on the development of worsening of anemia or thrombocytopenia Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy Prior pharmacological treatment for CLL Past history of anaphylaxis following exposure to monoclonal antibodies Active secondary malignancy or a history of malignant disease (other than CLL or non-melanoma skin cancer) within the preceding 5 years Any medical condition requiring systemic corticosteroids Active systemic infection Major systemic or other illness (including Coombs positivity and active hemolysis) that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results HIV positive by serologic testing Pregnant or nursing female Unwilling/unable to practice an acceptable form of contraception | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 3.0-999.0, Cutaneous Leishmaniasis Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion. Previous RX: No specific or putatively specific therapy for leishmaniasis (Sb, pentamidine, amphotericin B, imidazoles, allopurinol) Other diseases: No concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT) and kidney function tests (creatinine) | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Prostatic Neoplasms Patients with clinical stage T1-T4 carcinoma of the prostate Must have undergone radical radiation and at least 2 years of Pharmacological androgen ablation.Pharmacological androgen ablation may LHRH-agonists with or without Non-steroidal androgen ablation, Steroidal Anti-androgens, Progestational agents, and Cypoterone (Androcur) Must be currently 6 months or more after their last injection of LHRH-agonists if it was being given every 3 months or 4 months or more after their last injection, if it was being given monthly. If the patient was on oral androgen ablation agent, they must be off this medication for a period of at least 4 months currently off hormonal therapy Able to sign the consent form and fill out questionnaire used in the study No patients who have been treated, or are currently being treated with Bicalutamide no previous orchidectomy | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia Confirmed diagnosis of chronic lymphocytic leukemia (CLL) Stage 0, I, or II disease Previously untreated disease Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL Absolute lymphocyte count > 10,000/mm^3 Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically Phenotypically characterized B-CLL defined by all of the following A population of leukemic cells that co-expresses the B-cell antigen CD23 as well as CD5 in the absence of other T-cell markers (CD3, CD2, etc.) Dim surface immunoglobulin expression Exclusively κ or λ light chains | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 15.0-999.0, Leukemia Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following Previously treated stage III or IV or earlier stage disease with evidence of active disease, as defined by ≥ 1 of the following Weight loss > 10% within the past 6 months Extreme fatigue Fever or night sweats without evidence of infection Worsening anemia or thrombocytopenia Progressive lymphocytosis with a rapid lymphocyte doubling time Marked hypogammaglobulinemia or paraproteinemia Lymphadenopathy > 5 cm in diameter Previously untreated stage 0-II disease with symptoms or significant fatigue or at high risk of progression due to of B2 microglobulin > 3.0 mg/mL | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-75.0, Hepatic Encephalopathy Hepatitis C Liver Cirrhosis Phase A Subject is 18 to 70 years of age, inclusive Subject has cirrhosis due to chronic HCV infection as documented by Subject has evidence of hepatic encephalopathy as evidenced by Neuro-psychometric Testing (Number Connection Test, Trails Test, etc.) Subject is non-azotemic (creatinine <1.5mg/dL) and ambulatory at screening Subject has cirrhosis due to chronic HCV as documented by: pathologic or clinical and radiographic evidence of cirrhosis with a positive HCV RNA PCR level. Phase A Subject has received active interferon therapy within 2 weeks of enrollment Subject is pregnant or lactating Subject has a life expectancy of less than 100 days Subject has a history of alcohol abuse within 6 months of enrollment Subject has active gastrointestinal bleeding at time of enrollment Subject has used an agent that alters intestinal motility, eg, methadone, cholestyramine, tricyclic antidepressants Subject is unable to take oral medication Subject has used neomycin or other antibiotic within 2 weeks of enrollment or is actively using lactulose at time of enrollment Subject is taking or has hypersensitivity or allergy to rifaximin or rifampin Subject requires long term antibiotic therapy (eg, Lyme Disease, tuberculosis) | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group Meets 1 of the following Binet stage C disease Binet stage B disease AND ≥ 1 of the following signs or symptoms* B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers > 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue) Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count > 50 G/I) Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia Massive, progressive or painful splenomegaly or hypersplenism Massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy Occurrence of symptomatic hyperviscosity problems at leukocyte counts > 200 G/I (symptomatic leukostasis) NOTE: * Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above for active disease is not sufficient for | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-75.0, Prolymphocytic Leukemia Diagnosis of B-cell prolymphocytic leukemia Previously treated disease All Binet stages allowed Life expectancy > 3 months ECOG/WHO performance status 0-3 PRIOR No more than 3 prior treatment regimens | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia, Lymphocytic, Chronic Patients must have a histologic diagnosis of CLL as defined by the WHO and exhibit active disease requiring treatment as per the NCI working group on CLL. 2. Patients must have a fresh tumor specimen available (peripheral blood or bone marrow) for flow cytometry evaluation (e.g. CD40, CD38, CD20, CD19, and CD5).For the phase 2 portion of the study, CD40 expression on malignant cells must be confirmed prior to registration. 3. Patients must have relapsed after receiving at least one fludarabine containing regimen or an equivalent purine analog. At study start patients must be at least 8 weeks or 5 plasma half-lives (whichever is greater) from prior chemotherapy/radiation/investigational agents, 8 weeks from prior antibody therapy and 6 months from autologous stem cell transplant. 4. Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months. 5. Patients must have the following required baseline laboratory data Platelet count ≥ 50,000/mm3 (may be maintained by transfusion) Hemoglobin ≥ 7.5 g/dL (may be maintained by transfusions or growth factors) Absolute neutrophil count ≥ 1,000/mm3 (may be maintained by growth factors) ALT/AST ≤ 2.0 times ULN Total bilirubin ≤ 2.0 times ULN (unless related to hemolysis) Creatinine < 2.0 times ULN 6. Females of childbearing potential must have a negative B-hCG pregnancy test result within 3 days prior to the first dose and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug. 7. If a deep venous thrombosis or other vascular event has required medical or surgical intervention in the past year, patients must either: a) be on a stable dose of anticoagulant therapy (i.e., Coumadin and/or Heparin) for at least three weeks or b) have completed anticoagulant therapy at least three months prior to registration with radiographic confirmation that thrombosis is resolved. Prophylactic anticoagulant therapy for indwelling catheters is acceptable. 8. Patients must be at least 18 years of age. 9. Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution. 10. Patients must give written informed consent. A copy of the signed informed consent form will be retained by the treating institution Patients who have been treated previously with any anti-CD40 antibody. 2. Patients with a documented history within 6 months of registration of a cerebral vascular event (stroke or TIA), unstable angina, or myocardial infarction. 3. Patients with active CNS or leptomeningeal disease. 4. Patients who have received allogeneic stem cell transplant. 5. Patients who have had major surgery within four weeks prior to enrollment. 6. Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation. 7. Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit). 8. Patients with any systemic viral, bacterial, or fungal infection that has required antibiotic therapy within four weeks prior to enrollment. Prophylactic antibiotics and antiviral therapy are permitted prior to registration and are required during the study period (e.g. Bactrim, acyclovir). 9. Patients with known HIV, hepatitis B (by surface antigen expression), or active hepatitis C infection. 10. Patients on systemic steroids who have not been on a stable daily dose during the four weeks immediately prior to first dose of SGN-40. Maximum steroid dose is 10 mg prednisone per day or equivalent. 11. Patients with a history of migraines or severe headaches requiring medical therapy (other than occasional acetaminophen, aspirin, or non-steroidal anti-inflammatory drugs) within 12 months of enrollment. 12. Patients who are pregnant or breastfeeding. 13. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment. 14. Patients with dementia or altered mental status that would preclude the understanding and/or rendering of informed consent | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia, Lymphocytic, Chronic Ages 18 years and older Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen ECOG performance status of 0, 1, 2 or 3 Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug Pregnant or nursing Unable or unwilling to sign consent Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy Active serious infections that are not controlled by antibiotics ECOG performance status 4 Inadequate renal function: creatinine 2.0 or more unless related to the disease Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease Known positive test for HIV Patients with known hepatitis B and/or hepatitis C active infection | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 16.0-60.0, Lymphoma Confirmed diagnosis of previously untreated large B-cell Non Hodgkin's, Large Cell Lymphoma and B-Cell with high grade features. Other aggressive lymphomas such as Primary Mediastinal large B-cell Lymphomas will be also allowed to be included. 2. Patients with performance status of 0-2 (Zubrod Scale). 3. Serum bilirubin <1.5 mg/dl and serum creatinine < 2.0 mg/dl unless due to lymphoma; absolute neutrophil count (ANC) >1000/mm^3 and platelets >100,000/mm^3 unless due to lymphoma. 4. Cardiac ejection fraction 50% or greater. 5. Ages 16 years (due to the fact that CHOP-R is not studied enough in younger patients and is not considered standard of care). 6. Patients must be willing to receive transfusions of blood products. 7. Age adjusted International Prognostic Index Score of 2 or more 8. Previous steroids are allowed (if used to relieve some symptoms such as SVC, etc) Pregnancy (excluded due to the teratogenicity of the involved chemotherapy agents 2. Positive HIV serology because of poor tolerance to this intense chemotherapy regimen 3. Burkitt's lymphomas, and Mantle cell lymphoma, transformed follicular center cell lymphoma, follicular grade III. 4. Any clinical or cytological diagnosis of central nervous system (CNS) involvement 5. Any co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator. 6. Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival at 5 years) 7. Active Hepatitis B or C. Chronic carriers for Hepatitis B will be excluded | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Acute Myocardial Infarction patients with acute Myocardial infarction with ST elevation , and moving by ambulance to Poriya hospital women less than 50 years old and 80 years old, bleeding tendency, stroke in the past | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Prostatitis Pelvic Pain Male subjects aged 18 and older. 2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies 3. Subjects with a minimum score of 15 on the CPSI. 4. Male subjects must give written informed consent. 5. Male subjects must be willing an able to comply with the most recent version of the FDA-mandated S.T.E.P.S.â Program to He understands and can reliably carry out all instructions He is capable of complying with the mandatory contraceptive measures that are appropriate for male patient registration, and patient surveys as described in the S.T.E.P.S.â program He has received both oral and written warning of the hazards of taking thalidomide and exposing a fetus to the drug He has received both oral and written warning of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a late condom during any sexual contact with a woman of childbearing potential, even if he has undergone a successful vasectomy He acknowledges in writing his understanding of these warning and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy He agrees NOT to be a sperm or blood donor while being treated with thalidomide - Subjects who are female. 2. Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past six months 3. Subjects with duration of symptoms less than three months 4. Subjects with active genital infections 5. Subjects with prior urologic surgeries 6. Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate 7. Subjects having received prior radiation to the abdominal or pelvic area 8. Subjects with known bladder or ureteral calculi 9. Subjects unable to complete a voiding diary 10. Subjects diagnosed with neuropathy 11. Subjects with neutropenia 12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state 13. Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program 14. Subjects with orthostatic hypotension 15. Subjects with known malignancies in the last 2 years | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Refractory Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) by NCI-WG immunophenotype and blood Documentation of current or prior peripheral blood (PB) or bone marrow (BM) immunophenotype compatible with CLL Patients who currently do not have > 5,000/mm³ absolute lymphocytosis are eligible if they have previously met PB lymphocytosis and have a current immunophenotype documenting monoclonal B lymphocytosis morphologically and immunophenotypically compatible with CLL Intermediate-risk (Rai stage I or II) or high-risk (Rai stage III or IV) disease, including any of the following Rai stage I disease with lymphocytosis and enlarged nodes Rai stage II disease with lymphocytosis plus splenomegaly and/or hepatomegaly (nodes positive or negative) Rai stage III disease with lymphocytosis plus anemia Rai stage IV disease with lymphocytosis and thrombocytopenia Must require treatment with active disease, experiencing disease related symptoms, or having deterioration of blood counts, meeting ≥ 1 of the following Presence of ≥ 1 of the following disease-related symptoms | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Confirmed diagnosis of previously treated chronic lymphocytic leukemia (CLL) meeting the following Binet stage B (Rai stages I and II) or Binet stage C (Rai stages III and IV) disease Rapid disease progression, symptomatic enlarged lymph nodes, or severe B-cell symptoms CLL with autoimmune hemolytic anemia allowed Richter transformation allowed Life expectancy > 3 months ECOG performance status 0-3 No severe organ dysfunction No other prior or concurrent neoplasms PRIOR No more than 4 prior chemotherapy regimens | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, B-Cell Chronic Lymphocytic Leukemia (B-CLL) A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National Cancer Institute Working Group (NCI WG) Criteria World Health Organization (WHO) performance status of 0, 1, or 2 Life expectancy ≥ 12 weeks Previous therapy with at least one but no more than 5 regimens (single agent or combination regimen). One therapy regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting > 3 months Patient requires treatment for CLL per the following -Rai stage III or IV; -Rai stage 0-II with at least one of the following evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia; Massive (i.e. greater than 6 cm below the left costal margin) or progressive splenomegaly; Progressive lymphocytosis with an increase of greater than 50% over a 2-month period or an anticipated doubling time of less than 6 months; Lymphocyte count > 100*10^9/L; B symptoms More than 3 weeks since prior chemotherapy. Patient must have recovered from the acute side effects incurred as a result of previous therapy More than 3 weeks since using investigational agents. Patient must have recovered from the acute side effects incurred as a result of previous therapy Serum creatinine and conjugated (direct) bilirubin less than or equal to 2 times the institutional upper limit of normal (ULN) unless secondary to direct infiltration of the liver with CLL Female patients with childbearing potential must have a negative pregnancy test (serum or urine) within 2 weeks of first dose of study drug(s). All patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy Positive Coombs test and evidence of active hemolysis Platelet count less than 50*10^9/L without splenomegaly History of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies Previously treated with Previous bone marrow transplant Known central nervous system (CNS) involvement with B-CLL Active infection, including human immunodeficiency virus (HIV) positive Active second malignancy Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti-tuberculous medication (e.g., INH, rifampin, streptomycin, pyrazinamide, or others) Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb) test with a documented history of prior hepatitis B immunization are eligible as long as other are met (i.e. negative tests for: hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and hepatitis C virus antibody (HCVAb)) | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-85.0, T-LGL Lymphoproliferative Disorders Clinical history supportive of the diagnosis of T-LGL leukemia (i.e. a history of cytopenias with peripheral blood morphologic evidence of LGLs) Immunophenotypic studies of peripheral blood showing an increased population of T-LGLs (suggested by staining with CD3+, CD8+ and CD16+ or CD57+) or gammadelta T cells Restricted or clonal rearrangement of the T-cell receptor by PCR AND one or more of the following: Severe neutropenia (less than 500 neutrophils/microliter); OR Severe thrombocytopenia (less than 20,000 platelets/microliter), or moderate thrombocytopenia (less than 50,000 platelets/microliter) with active bleeding; OR Symptomatic anemia with a hemoglobin less than 9 g/dL or red blood cell transfusion requirement of greater than 2 units/month for two months prior to initiation of Campath Ages 18-85 (both inclusive) A reactive LGL lymphocytosis to a viral infection Serologic evidence of HIV infection Infection not adequately responding to appropriate therapy Previous immunosuppressive therapy with alemtuzumab History of carcinoma that is not considered cured (excluding non-melanoma skin carcinoma) Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the subject's ability to tolerate protocol therapy or that death within 7-10 days is likely Current pregnancy, or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential Not able to understand the investigational nature of the study or give informed consent | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 12.0-60.0, Cutaneous Leishmaniasis Parasitologically proven cases of CL based on positive smear and/or culture Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician) Age 12-60 years Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years) Pregnant or lactating women Duration of lesion more than 6 months Number of lesions more than 4 Ulcer size greater than 4 cm in their largest diameter History of full course of standard treatment (antimonials) History of allergy to Glucantime Serious systemic illnesses (as judged by the physician) Participation in any drug trials in the last 60 days | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Astrocytoma Glioma Oligodendroglioma Patients must have histological or neuroradiographic documented recurrent glioma defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma. All patients must have had prior pathologic confirmation of primary tumor histology Patients must be > than or equal to 18 years old Patients must have a Karnofsky performance score (KPS) of > or equal to 50 Measurable disease per MacDonald is required Patients must have a predicted life expectancy of at least 12 weeks Required initial laboratory data: 1. Absolute Neutrophil Count (ANC) > 1,500 2. Platelets > 100,000 3. Serum Creatinine < 2.0 4. Serum Bilirubin < 2.0 5. Aspartamine transaminase/ Alanine transaminase (AST/ALT) < 3x normal 6. Pregnancy test for females with child-bearing potential negative Patients must sign and date an IRB approved informed consent form stating he or she is aware of the neoplastic nature of the disease. Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (Human protection committee approval of this protocol and consent form is required) Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up Patients must have been previously treated with both surgery and radiotherapy Prior adjuvant and one salvage chemotherapy regimen is permitted Patients have evidence of leptomeningeal spread of disease Patients having been treated with 2 or more salvage regimens Pregnant or breast-feeding women. With the exception of post-menopausal or infertile women, a negative blood test for pregnancy is mandatory before entry on study. Fertile persons refusing to use adequate contraceptives may not participate Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic diarrhea or presence of a bowel obstruction Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia Known to be human immunodeficiency virus (HIV) positive or to have an acquired immunodeficiency syndrome (AIDS) related illness Patients with an active infection that is not adequately controlled with antibiotics Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 0.0-999.0, Leukemia Lymphoma Diagnosis of CLL, Small lymphocytic lymphoma (SLL), or -cell prolymphocytic leukemia (T-PLL). 2. Previously treated with chemotherapy or monoclonal antibodies. 3. All patients with Rai stage III-IV are eligible Patients with Rai stage 0-II who meet one or more indication for treatment as defined by the NCI-sponsored Working Group are eligible:Massive or progressive splenomegaly; Massive lymph nodes, nodal clusters, or progressive lymphadenopathy; Grade 2 or 3 fatigue, fever >/= 100.5 degrees F, night sweats for > 2 weeks w/o documented infection, presence of weight loss >/= 10% over the preceding 6 months; Progressive lymphocytosis with increase in lymphocyte count of >/= 50% over a 2-month period or an anticipated doubling time of < 6 months. 4. Serum bilirubin less than 2mg/dL, serum creatinine less than 2mg/dL unless abnormality is considered due to CLL by investigator. 5. The Eastern Cooperative Oncology Group (ECOG) Performance Status < 3. 6. Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital. 7. Sexually active women of childbearing potential must use birth control during study in manner that risk of failure is minimized. Prior to study enrollment women of childbearing potential must be advised of importance of avoiding pregnancy during trial and potential risk factors for unintentional pregnancy. MUST have negative pregnancy test. If pregnancy test is positive patient must not receive investigational product and must not be enrolled in study. Men enrolled on study should understand risks to sexual partner of childbearing potential and practice effective birth control. 8. of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. There are no exclusions of women or minorities based on the study objectives. 9. New York Heart Association (NYHA) Class < 3 10. Patients must sign informed consent Pregnant or breast-feeding women are excluded. 2. Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, G-CSF, GM-CSF etc. 3. Patients must not have untreated or uncontrolled life-threatening infection. 4. Uncontrolled angina within 3 months; diagnosed or suspected congenital long QT syndrome; any history of clinically significant ventricular arrhythmias; prolonged QTc interval (> 450 msec); uncontrolled hypertension; significant bleeding disorder unrelated to cancer; patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes. 5. Medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) or Anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]) | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-60.0, Renal Transplant primary renal transplant (not HLA identical) ages 18-60 years recipient panel reactive antibody level >10% recipient of a DCD kidney no prior organ transplant no multi-organ transplant recipient no subject who is currently receiving systemic corticosteroids no pregnant or lactating subjects no history of Hepatitis B, C or HIV positivity no recipient of a kidney with cold ischemia time >36 hours | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 21.0-99.0, Refractory Chronic Lymphocytic Leukemia Patients diagnosed with Chronic Lymphocytic Leukemia Prior therapy with fludarabine or a fludarabine containing regimen CD20 expression on CLL cells Neutrophil count ANC greater than 500/mm(3) Platelet count greater than 30K/mm(3) Age 21-99 Bulky lymphadenopathy, defined as greater than 1 lymph node with greater than 5cm in largest diameter Evidence for transformation into high grade lymphoma (Richter's transformation) ECOG performance 3 or higher Other concurrent anticancer therapies Less than 3 months from last systemic therapy for CLL Less than 6 months from last monoclonal antibody therapy More than 10 doses rituximab, within 12 months preceeding protocol enrollment, either as single agent or in a combination chemotherapy regimen Chronic or current clinically significant infection, including HIV positivity or hepatitis C Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy History of mucocutaneous reactions (paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis) | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Cytopenia acute leukemia receiving remission induction chemotherapy receiving antibiotic prophylaxis for cytopenia leukocytes lower than 1000/mm3 in peripheral blood) informed consent none | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 0.0-999.0, Chronic Lymphocytic Leukemia Untreated CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) with indication for therapy. Indications for therapy at least one of the following: (1) one or more disease-related symptoms [fever, night sweats, weight loss > 10% in prior 6 months, pronounced fatigue]; (2) advanced stage disease (Rai stage >/= 3 or Binet stage C); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of < 6 months Patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) Beta-2-microglobulin </= 4 mg/dL Adequate liver function (total bilirubin </= 2.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) </=4 x ULN) and renal function (serum creatinine </= 2.0 mg/dL and/or creatinine clearance < 30 mL/hour). Patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the Principal Investigator, but upper limits for creatinine even under these circumstances must be creatinine < 3mg/dL and bilirubin < 6 mg/dL. Patients with Gilbert's syndrome may be entered on study with bilirubin levels </= 4 mg/dL Eastern Cooperative Oncology Group (ECOG) performance status </= 2 Signed informed consent in keeping with the policies of the hospital Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as >/= 1 year after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment Active hepatitis B (at least one of the following markers positive: HBsAg, hepatitis B e antigen (HBeAg), immunoglobulin M (IgM) anti-HBc, hepatitis B virus (HBV) DNA) Concurrent chemotherapy or immunotherapy Pregnant patients History of HIV Symptomatic central nervous system (CNS) disease | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Signed, written EC-approved informed consent form Diagnosis of relapsed CD23+ and CD20+ B cell CLL as defined by NCI WG guidelines Subjects who have received at least 1 but no more than 2 prior single agent or combination treatments for CLL Rai Stage III or IV (Binet Stage C), or Rai Stage I or II (Binet Stage A or B) if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms (Staging Modified Rai) WHO Performance Status less than or equal to 2 Age greater than or equal to 18 years Male and female subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment Acceptable liver function: bilirubin less than or equal to 2.0 mg/dL (26 µmol/L); AST and ALT less than or equal to 2 times upper limit of normal Acceptable hematologic status: platelet count greater than or equal to 50 x 10^9/L should be unsupported by transfusion; ANC greater than or equal to 1 x 10^9/L Subjects who are refractory to the following combination therapies: purine analogue + R, purine analogue + C, or purine analogue + CR. Refractory is defined as not achieving at least a PR for a minimum duration of 6 months as determined by treating physician. Purine analogues fludarabine, pentostatin and cladribine Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1 Previous exposure to lumiliximab or other anti-CD23 antibodies Prior autologous or allogeneic BMT or hematopoetic stem cell transplant Known infection with HIV, hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects considered at high risk of hepatitis B or hepatitis C infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B or hepatitis C exposure are excluded unless the serological findings are clearly due to vaccination Uncontrolled diabetes mellitus Uncontrolled hypertension Transformation to aggressive B-cell malignancy (e.g., large B cell lymphoma, Richter's Syndrome, or PLL) Secondary malignancy requiring active treatment (except hormonal therapy) Any medical condition that would require long-term use (>1 month) of systemic corticosteroids during study treatment. However, steroid use less than or equal to 1 month is permissible during the study | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-75.0, Multiple Myeloma Lymphoma, Non-Hodgkin's (Abbreviated List) Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) Eligible for autologous transplantation <=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study) >4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study) Total dose of melphalan ≦200 mg Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 White blood cell (WBC) count >3.0*10^9/L prior to first dose of G-CSF Absolute polymorphonuclear leukocyte (PMN) count >1.5*10^9/L prior to first dose of G-CSF Platelet (PLT) count >100*10^9/L prior to first dose of granulocyte colony-stimulating factor (G-CSF) (Abbreviated List) A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications Failed previous stem cell collection or collection attempts A residual acute medical condition resulting from prior chemotherapy Active brain metastases or carcinomatous meningitis Active infection requiring antibiotic treatment Received prior radio-immunotherapy with Zevalin or Bexxar Received bone-seeking radionuclides (e.g., holmium) Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF History of ventricular arrhythmias, including electrocardiogram (ECG)-documented premature ventricular contractions (PVCs), during the last 3 years | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Cystic Fibrosis Phlebitis Diagnosis of cystic fibrosis, made accordingly to the Cystic Fibrosis Foundation Guideline (Rosenstein BJ. J Pediatr 1998;132: 589-595) age of 18 years or more and ability to consciously express owns informed consent have a prescription done by one of the CF Centre specialist Physicians of an IV antibiotic course of the expected duration of 2 weeks, due to a pulmonary exacerbation, with the association of ceftazidime 3 times daily and tobramycin once daily diluted in Normal Saline absence of clinical conditions that contraindicate the administration of 350ml of Normal Saline in 30 minutes 3 times daily and of 400ml of Normal Saline in 40 minutes no simultaneous anti-inflammatory therapy administered orally, IM or IV days have passed from the end of the previous course The IV course will be given to the subject as an inpatient, and he or she will be admitted to our hospital | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Patients with type 2 diabetes mellitus Having been treated with any other insulin, but who did not reach the target of A1c=7% Ability and willingness to perform Self Monitoring Blood Glucose measurement Will follow the prescribing information (Summary of Product Characteristics). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Polycythemia Vera Essential Thrombocytosis Idiopathic Myelofibrosis Neutrophils Chronic Myeloproliferative Disorders Diagnosis or suspected diagnosis of PV, ET, or IMF. The World Health Organization will be used for diagnosing this disorder. In brief, the for PV is hemoglobin greater than 18.5 g/dL in men and greater than 16.5 g/dL in women and splenomegaly on palpation in the absence of secondary erythrocytosis. If splenomegaly is absent, the patient must have 2 of the following 4 minor platelet count greater than 400 x 10(9)/L, leukocyte count greater than 12 x 10(9)/L, marrow biopsy with trilineage increase in cellularity, and low serum erythropoietin level. The for EF is a platelet count greater than 600 x 10(9)/L with no known cause of reactive thrombocytosis and a normal hemoglobin. The for IMF is fibrosis of the bone marrow and splenomegaly without preceding PV, ET or chronic myelogenous leukemia. 2. Both male and female subjects will be studied. 3. Any ethnic group. 4. 18 years of age or older Subjects will be excluded if they have any of the following conditions: 1. Increased blood counts due to a disease other than chronic myeloproliferation. 2. Know history of anemia (hematocrit less than 12.0 mg/dL). 3. Pregnancy. 4. Infection with HIV, hepatitis B, or hepatitis C | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-120.0, Leukemia Lymphoma Lymphoproliferative Disorder Biopsy-proven* relapsed or refractory lymphoma, including the following Aggressive lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma) Transformed lymphoma Diffuse large B-cell lymphoma Mantle cell lymphoma Grade 3 follicular lymphoma Precursor B-cell lymphoblastic leukemia/lymphoma Mediastinal (thymic) large B-cell lymphoma Burkitt's lymphoma/leukemia Precursor T-cell lymphoblastic leukemia/lymphoma | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 21.0-999.0, Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). 2. Failed prior standard of care therapy for CLL. 3. Neutrophil count (ANC) greater than or equal to 500/microliter (mcL). 4. Platelet count greater than or equal to 20,000/mcL. 5. Age 21-99 Chronic or current clinically significant infection, including HIV positivity or uncontrolled infection. 2. Eastern Cooperative Oncology Group (ECOG) performance greater than 2. 3. Other concurrent anticancer therapies. 4. Less than 4 weeks from last systemic therapy for CLL. Steroids up to 2 weeks before the start of treatment are permissible. 5. Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy. 6. Creatinine greater than 1.5 times the upper limit of normal. 7. Women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception. 8. Men who are unwilling to use a barrier protection. 9. Inability to understand the investigational nature of the study; inability to provide informed consent | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Advanced CLL, defined as no response or progressive disease during standard nucleoside analogue based regimen; or, evidence of progressive disease within 24 months of completion of nucleoside analogue regimen; or, intolerance to fludarabine; or, failure to achieve complete remission following salvage regimen no sites of adenopathy > 5cm (8/8) HLA matched related or unrelated donor available Must have prior banked tumor, collected by peripheral blood draw, leukapheresis, bone marrow biopsy or by lymph node dissection, per DF/HCC protocol 06-200 ECOG performance status 0-2 Serum creatinine greater than or equal to 2.0mg/dl ALT or AST greater than or equal to 3x ULN Total bilirubin greater than or equal to 2.0mg/dl (except for patients with Gilbert's syndrome) Cardiac ejection fraction greater than or equal to 30% HIV infection Pregnancy | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Melanoma (Skin) Histologically confirmed primary melanoma of cutaneous origin Stage II (T3 N0 M0 1.5-4.0mm Breslow depth Clinically negative regional lymph node pathologic status unkown OR Histologically negative regional lymph nodes Stage III (T4 N0 M0) Greater than 4.0mm Breslow depth OR Stage III (T1-4 N1) One lymph node positive microscopically Patients must meet at least 1 of the following T2b N0 primary melanoma 1.01-2.0mm with ulceration, node negative Biologic Therapy No prior immunotherapy including tumor vaccines, interferon, interleukins,levamisole, or other biologic response modifers for melanoma Chemotherapy No prior or concurrent chemotherapy Endocrine Therapy No concurrent systemic corticosteriods including oral steriods (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steriod-containing inhalers. Radiotherapy No Prior or concurrent radiotherapy Surgery See Disease characteristics Other No other concurrent immunosuppressive medications No other history of invasive melanoma No autoimmune disorders or conditions of immunosuppression No other concurrent or prior malignancies within past 5 years | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 0.0-999.0, Chronic Lymphocytic Leukemia Diagnosis of B-cell CLL Relapsed, fludarabine-sensitive (duration of response > 6 months as assessed by prior treating physician) or fludarabine-naive patients Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms Prestudy WHO Performance Status </= 2 Signed, written Institutional Review Board (IRB)approved informed consent Men and women of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment Acceptable liver function: Bilirubin </= 2.0 mg/dL (26 umol/L), AST (SGOT) and/or ALT (SGPT) </= 2 times upper limit of normal Acceptable hematologic status: Platelet count >/= 50 x 10^9/L., absolute neutrophil count (ANC) >/= 1 x 10^9/L Acceptable renal function: Serum creatinine </= 2.0 mg/dL Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1 Known infection with HIV, hepatitis B, or hepatitis C Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia [PLL]) Patients with secondary malignancy requiring active treatment (except hormonal therapy) Active uncontrolled bacterial, viral, or fungal infections New York Heart Association Class II-IV cardiac disease or myocardial infarction within the past 6 months prior to Study Day 1 Pregnant or currently breast-feeding Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study Blood pressure of > 150/100 mmHg Unstable angina | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia Histologically or cytologically confirmed Richter's transformation, fludarabine-refractory chronic lymphocytic leukemia or prolymphocytic leukemia. 2. Patients must be 18 years of age or older. 3. Patients must have a performance status of 0-2 (Zubrod scale). 4. Patients must have adequate renal function (serum creatinine below or equal to 2mg/dL or creatinine clearance greater than 30mL/min), unless renal dysfunction is considered due to organ infiltration by disease. 5. Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times the upper limit of normal (ULN) for the reference lab unless considered due to leukemia or congenital hemolytic disorder (for bilirubin). 6. Female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception. 7. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital. 8. Patients must have platelet counts greater or equal to 20,000, unless due to disease involvement, or autoimmune disorders Untreated or uncontrolled life-threatening infection. 2. Oxaliplatin, fludarabine, cytarabine or rituximab intolerance. 3. Pregnancy or lactation. 4. Chemotherapy and/or radiation therapy within 4 weeks. 5. Medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Kidney Cancer Histologically or cytologically confirmed renal cell carcinoma (any histology) based on prior biopsy or biopsy performed and reviewed at Cleveland Clinic Foundation. This can pathology read as adenocarcinoma consistent with renal origin Unresectable primary tumor due to any of the following factors or various combinations thereof Large tumor size (> 15 cm) Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels) Venous thrombosis (high level/invasive disease requiring inferior vena cava reconstruction or hypothermic circulatory arrest) Proximity to vital structures (e.g., mesenteric vasculature) Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (<50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable. The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability Patients with history of brain metastases can be enrolled 2 weeks following the completion of gamma knife or whole brain radiotherapy ECOG performance status (PS) 0-1 or Karnofsky PS >/=70% Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 times upper limit of normal (ULN) The presence of any of the following will a patient from study enrollment Prior systemic treatment for RCC Evidence of bleeding diathesis or coagulopathy. Patients with hematuria from the primary renal tumor are eligible provided all other are met Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism Hypertension that cannot be controlled by medications to < 160/90 mmHg Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness Pregnancy or breastfeeding Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Hepatocellular Carcinoma Age > 18 years ECOG PS 0-2 Histologically or cytologically documented unresectable and/or metastatic HCC Measurable disease by criteria Previous local therapy completed > 6 weeks Any acute toxicity (CTC-AE) < grade 1 Child-Pugh A Liver transaminases ≤ 5 x ULN Albumin ≥ 2.8 g/dl Serum total bilirubin ≤ 3 mg/dl Metastatic brain/leptomeningeal tumors Prior or concomitant systemic anti-cancer treatment for HCC, including Systemic chemotherapy (TACE is allowed) Immunotherapy Hormonal therapy (hormonal therapy used for supportive used is allowed) Raf-kinase inhibitors MEK inhibitors Farnesyl transferase inhibitors VEGF/VEGFR inhibitors or other anti-angiogenesis agents | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Richter's Transformation Leukemia All patients with histologically or cytologically confirmed Richter's transformation, prolymphocytic leukemia, aggressive, or relapsed/refractory B-cell chronic lymphocytic leukemia are eligible for this protocol Patients must be 18 years of age or older Patients must have a performance status of 0-2 (Zubrod scale) Patients must have adequate renal function (serum creatinine <= 2 mg/dL or creatinine clearance > 50 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the principal investigator (PI) and consideration of appropriate dose adjustments Patients must have adequate hepatic function (bilirubin <= 2 mg/dl; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 2.5 * the upper limit of normal (ULN) for the reference lab unless due to leukemia or congenital hemolytic disorder [for bilirubin]). Patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the PI and consideration of appropriate dose adjustments Female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception Patients must sign an informed consent indicating that they are aware of the investigational nature of this study Patients must have platelet counts > 20,000, unless lower counts are due to disease involvement or autoimmune disorders Untreated or uncontrolled life-threatening infection Oxaliplatin, fludarabine, cytarabine or rituximab intolerance Pregnancy or lactation Chemotherapy and/or radiation therapy within 4 weeks Medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 45.0-90.0, Lung Diseases Bronchitis, Chronic Male or female out-patients >/= 45 years Subjects suffering from chronic bronchitis FEV1</= 70% and FEV1/FVC </= 70% predicted from age, height and sex No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening Sputum production on most days, even when exacerbation free Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening Smoking history of at least 20 pack-years Subjects willing and able to give fully informed written consent Subjects with contra-indications to moxifloxacin Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis Subjects who are actively participating in intensive pulmonary rehabilitation programs Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included) | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 50.0-999.0, Osteoporosis Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/ apply. All must be answered "yes" for a subject to be enrolled in the trial. 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject female and at or above the age of 50? 3. Has the subject been postmenopausal for more than 5 years in the judgement of the investigator? 4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia? 6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for evaluation? [*] 7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper? [*] Note that no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also and note [**] All must be answered "no" for a subject to be enrolled in the trial. Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: 5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted. 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? according to the investigator's opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**] 17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**] 18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**] 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**] 20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**] 21. have severe impaired liver function ? [**] 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? according to the investigator's opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed. [**] no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-70.0, Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse aggressive non-Hodgkin lymphoma b cells age 18-70 bilirubin less then 2 creatinine less then 2 Pet/CT performed post 2 cycles no PET/CT post 2 cycles performed bilirubin >2 creatinine more then 2 HIV positivity | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Prostate Cancer Patient must have androgen independent Stage IV prostate cancer, with anaplastic features as defined by at least one of the following: a) Histologic evidence of small cell(pure/mixed), locally advanced or metastatic; b) Any of the following at Dx: exclusive visceral mets, predominant lytic mets, bulky ( >/= 5 cm) lymphadenopathy, or bulky ( >/= 5 cm) high-grade (Gleason >/= 8) tumor mass in the prostate/pelvis c) Low prostate-specific antigen (PSA) at diagnosis (Dx) + high volume bone mets. 2. (#1 cont'd) d) Neuroendocrine markers in histology (+ Chromogranin A and/or Synaptophysin) or serum (abnl high serum Chromogranin A or Bombesin) at Dx or at progression plus any of the following: elevated serum lactate dehydrogenase (LDH), malignant HyperCa+, or elevated serum Carcinoembryonic Antigen (CEA) in the absence of other etiologies. e) Short interval (< 6 months) to androgen-independent progression following initiation of hormonal therapy with or without presence of neuroendocrine markers. 3. Patients with small cell carcinoma on histology are not required to have received prior androgen deprivation therapy (ADT). All other patients must have evidence of disease progression while on ADT or an unsatisfactory response to >/= 1 month of castration, as defined by lack of symptom control and/or serum tumor marker response of < 20% (confirmed by a second value drawn on a different day). 4. Zubrod performance status of </= 2. 5. Normal EKG or, if EKG is suggestive of cardiomyopathy, patient has a resting Left Ventricular Ejection Fraction (LEVF) >/= 50% within 4 months. 6. Patient has all of the following pretreatment laboratory data within 14 days before registration: • Absolute neutrophil count (ANC) >=1,500/mm^3.(unless due to bone marrow infiltration by tumor, in which case ANC >/= 500/mm^3 are allowed). • Platelets >=100,000/mm^3 (unless due to bone marrow infiltration by tumor, in which case platelets >/= 20,000/mm^3 are allowed) 7. (#7 cont'd) • Total bilirubin </= 2 mg/dl; if greater, conjugated bilirubin should be <= 1.0 mg/dL, • serum glutamate pyruvate transaminase (SGPT) (ALT) and/or serum glutamate oxaloacetate transaminase (SGOT) (AST) </= 4 times the upper limit of normal (ULN). • Creatinine clearance >/= 40 (either measured or calculated by Cockcroft formula) • Castrate levels of serum testosterone (</= 50ng/mL) if no small cell elements on histology. (If small cell, testosterone > 50ng/mL) 8. Patient has given voluntary written informed consent before performance of any study-related procedure not part of standard medical care Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of registration. 2. 2 or more prior chemotherapy regimens (ketoconazole, aminoglutethimide or dutasteride do not count as chemotherapy for this trial). 3. Prior Platinum, Etoposide, or Taxane-based therapy that was completed less than 6 months from registration. 4. Samarium-153 within four weeks of registration, or Strontium-89 within 12 weeks of registration. Patients who have received 2 or more doses of bone-seeking radioisotopes are not eligible. 5. Patient has not recovered from all serious toxic effects of previous chemotherapy, radiation or antibody therapy, or from previous major surgery. 6. Patients with symptomatic and untreated brain metastases or central nervous system disease will be excluded. Patients with untreated, asymptomatic brain metastasis (not requiring corticosteroid treatment for control of central nervous system (CNS) symptoms) may be eligible, at the discretion of the MDACC Principal Investigator. Patients with treated brain metastases are eligible. 7. Patient with significant atherosclerotic disease, as defined by: a) myocardial infarction within six months of enrollment. Current uncontrolled/unstable angina pectoris or electrocardiographic evidence of acute ischemia b) clinically significant ventricular arrhythmias c) symptomatic congestive heart failure (NYHA Class III) 8. Patient has >= Grade 2 peripheral neuropathy. 9. Patient has renal insufficiency with cranial cruciate ligament (CrCL) < 40 ml/min with non-correctable etiologies. 10. Patient has an uncontrolled intercurrent illness (e.g., active infection). 11. Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the patient's ability to provide informed consent or with the completion of treatment according to this protocol | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Melanoma Histologically confirmed diagnosis of melanoma Progressive disease that is not surgically resectable, or metastatic Stage IV Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal No prior chemotherapy Measurable disease ECOG performance status ≤ 1 At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy Prior immunotherapy allowed Adequate organ function Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment Primary ocular or mucosal melanoma Bone-only metastatic disease History or presence of brain metastasis or leptomeningeal disease Significant medical disease other than cancer Organ allograft | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-65.0, Diffuse Large B Cell Lymphoma Age 18-65 years Diagnosis of Diffuse Large B-Cell Lymphoma Adverse Prognosis = Stage 3 or 4 and elevated LDH No more than one prior cycle of R-CHOP chemotherapy Adequate cardiac function No central nervous system involvement by lymphoma Histological diagnosis other than Diffuse Large B-cell Lymphoma Pregnant or lactating females Use of other anti-cancer therapies Other serious illness that would compromise study participation Prior malignancy Prior stem cell transplant or radiotherapy | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-70.0, Chronic Heart Failure Patients That Have Received a Left Ventricular Assist Device Patients that have had a left ventricular assist device (LVAD) implanted for chronic heart failure, where chronic heart failure is defined as at least 6 months Patients are clinically stable in the opinion of the clinical team looking after the patient Written informed consent <18 or >70 years of age at the time of consent Pregnancy or within 6 months of giving birth Women of child-bearing potential not using an effective method of contraception Men not using an effective method of contraception Suspected or active viral, fungal or parasitic infection within 48 hours prior to administration of IMP, in the opinion of the investigator* Patients at a high risk of thrombosis in the opinion of the investigator Patients with a previous episode of LVAD thrombosis Patients with persistently raised lactate dehydrogenase (LDH >2.5 ULN) Patients requiring triple anticoagulation i.e. warfarin and dual anti-platelet Patients participating in another clinical trial | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-65.0, Cutaneous Leihmaniasis Gender: Male Age: Adults Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion Previous treatment for leishmaniasis, specific or putatively specific therapy (Sb, pentamidine, amphotericin B, imidazoles, allopurinol) Other concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT), values of pancreatic function (lipase), kidney function tests (creatinine), and EKG | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-100.0, HIV Infections Under this protocol, cell recipients must fulfill all of the following characteristics and conditions: Greater than or equal to 18 years old Ability to sign informed consent For women of child-bearing potential, negative result on a serum or urine pregnancy test; in addition, men and women of childbearing potential must agree to practice abstinence or use two methods of birth control/contraception (condoms, diaphragm or cervical cap with spermicide, IUD, or hormonal-based contraception) for at least 4 weeks after each cell infusion Willingness to comply with study requirements and procedures including storage of blood for possible future use to study HIV/AIDS, related diseases, or the immune system Willingness to permit HLA testing Hematocrit greater than or equal to 27 percent, platelets greater than or equal to 25,000/mm (3) No significant underlying cardiac, renal, or hepatic disease (Creatinine less than 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 150 U/mL) HIV infection must be confirmed by ELISA and a confirmatory test (e.g. western blot if not previously documented, and patients must be under the care of a primary care physician. Viral load greater than 10,000 copies/mL on available optimized combination antiretroviral therapy, to at least 3 drugs, one of which is a non-nucleoside reverse transcriptase inhibitor (NNRTI), integrase inhibitor, or protease inhibitor. Patients not on combination antiretroviral therapy will be eligible, but must be willing to resume combination antiretroviral therapy and to have had a viral load greater than 10,000 copies/mL after at least 2 weeks of therapy. Failure or intolerance of at least two previous combination antiretroviral regimens. Failure will be defined as an HIV viral load greater than 400 copies/mL while taking a given regimen. Recipient must be taking appropriate prophylaxis for opportunistic infections, as per Public Health Service (PHS) guidelines, unless there is intolerance to available medications. Screening CD4+ cell count less than or equal to 350 cells/mm(3) obtained within 6 weeks prior to study entry FOR An individual will be ineligible to receive cells if one or more of the following conditions are present: Discordance with donor on antibody status of EBV, CMV, or HHV-8 if donor is antibody positive for EBV, CMV, or HHV-8. Malignancy requiring systemic therapy, or a history of malignancy that required myelotoxic chemotherapy. Active untreated opportunistic infection that requires systemic therapy. Patients with opportunistic infections who have received greater than 2 weeks of therapy will be eligible. Is pregnant or breast feeding. Severe psychiatric disorder that would interfere with adherence to protocol requirements. Individuals who have a stable psychiatric condition may be eligible. Current use or a history of treatment with investigational agent(s) within 3 months of protocol enrollment. ARVs obtained through expanded access programs are permitted. Current use or a history of treatment with a systemic corticosteroid, immunosuppressive, or cytotoxic agent within 30 days of protocol enrollment. Any other medical condition for which the investigator believes cell transfer may be contraindicated. Ever been diagnosed with autoimmune vasculitis. DONOR: Donor as specified by the FDA will be followed, except for HIV testing. All donors will be HIV positive as per protocol and as described in the IND application. Under this protocol, cell donors must fulfill all of the following characteristics and conditions: Greater than or equal to 18 years old. Ability to sign informed consent. For women of child-bearing potential, negative result on a serum or urine pregnancy test. Willingness to comply with study requirements and procedures including storage of blood for possible future use to study HIV/AIDS, related diseases, or the immune system. Willingness to permit HLA testing. Matched to at least one HLA-B allele of the potential recipient. The match will be at a two-digit resolution HLA allele level of typing or higher. Hematocrit greater than or equal to 30 percent, platelets greater than or equal to 100,000/mm(3), white blood cells greater than or equal to 3.0 times 10(9)/L. No underlying cardiac, pulmonary, renal, or hepatic disease that would preclude patient from undergoing apheresis. HIV infection must be confirmed by ELISA and a confirmatory test (e.g. western blot if not previously on record, and patients must be under the care of a primary care physician. HIV infection for greater trhan or equal to 7 years. For patients with a history of no or minimal (one or two nucleotide reverse transcriptase inhibitor (NRTI) drugs) prior antiretroviral therapy: CD4+ cell count greater than or equal to 400 cells/mm(3) and HIV viral load less than 50 copies/mL, with no recorded HIV viral load obtained after acute HIV infection greater than 2,500 copies/mL. For patients currently receiving antiretroviral therapy: no antiretroviral therapy for a period of at least 7 years prior to starting antiretroviral therapy, with CD4+ cell count greater than or equal to 400 cells/mm(3) and HIV viral load < 50 copies/mL at the time of initiation of antiretroviral therapy, and no recorded HIV viral load obtained after acute HIV infection > 2,500 copies/mL. HIV viral loads obtained during acute HIV infection (within 6 months of the estimated date of seroconversion) will not be utilized for study inclusion/exclusion. Minimum wt of 110 lbs<TAB> FOR DONOR: An individual will be ineligible to donate cells if one or more of the following conditions are present: Ever having been diagnosed with any AIDS-defining illnesses Positive results on screening test for any of the following tests: HCV enzyme immunoassay (EIA) repeat reactive/ recombinant immunoblot (RIBA) confirmed, HBV/HCV NAT, HTLV-I/II antibodies, T.cruzi antibodies, HBsAg, or serologic test for syphilis (with positive confirmatory treponemal-based assay), unless the patient has received adequate therapy for syphilis. Donors with a positive West Nile Virus NAT are deferred for 120 days. Is pregnant or breast feeding HLA homozygous donor who is haplo-identical to recipient History of malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of cervix or colon ALT or AST greater than 2 times the upper limit of normal Been diagnosed with malaria Been diagnosed with Chagas disease Been diagnosed with babesiosis Received a dura mater (or brain covering) graft Been diagnosed with any neurological disease Relative had Creutzfeldt-Jakob disease Had a transplant or other medical procedure that involved being exposed to live cells, tissues, or organs from an animal Had a sexual partner or a member of the household have a transplant or other medical procedure that involved being exposed to live cells, tissues, or organs from an animal Severe psychiatric disorder that would interfere with adherence to protocol requirements. Individuals who have a stable psychiatric condition may be eligible. Current use or a history of treatment with investigational agent(s) within 3 months of protocol enrollment. Current use or a history of treatment with a systemic corticosteroid, immunosuppressive, or cytotoxic agent within 30 days of protocol enrollment. Any other medical condition for which the investigator believes apheresis may be contraindicated | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Recurrent Skin Cancer Squamous Cell Carcinoma of the Skin Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Diagnosis of 1 of the following Histologically or cytologically confirmed squamous cell carcinoma of the skin Unresectable or metastatic disease Squamous cell histology represents ≥ 50% of the biopsy specimen May or may not be related to autologous or allogeneic organ transplantation Chronic lymphocytic leukemia (CLL) RAI stage 0-I Stable disease Patients with basalosquamous cell disease (basal cell with squamous differentiation) are eligible Measurable disease, defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-65.0, Leukemia Diagnosis of B-cell chronic lymphocytic leukemia (CLL), meeting the following Binet classification stages B or C Del 17 p (FISH) negative (< 10 % positives cores) Matutes score 4 or 5 Transformation to aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukemia) ECOG performance status ≥ 2 Life expectancy < 6 months Creatinine clearance < 60 mL/min Total bilirubin > 2 x upper limit of normal (ULN) Gamma glutamyltransferase or transaminase levels > 2 x ULN Cumulative illness rating scale > 6 HIV seropositivity | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 6.0-999.0, Hemophilia B Patients with moderate to severe hemophilia B ( < 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens. 2. HIV seropositive ( asymptomatic) or seronegative subjects. 3. No history or detectable inhibitors | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2 Treatment failure in more than 3 prior regimens Active secondary malignancy Central nervous system involvement with CLL History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy History of HIV positivity Hepatitis C virus (HCV) positivity based upon core antigen testing Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents Pregnancy or lactation Other severe, concurrent diseases or mental disorders | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 19.0-999.0, Traumatic Complication of Injury Adult patient 19 years and older Sustained trauma injuries with Injury Severity Score greater than 9 Under 19 years of age Prisoners Pregnancy Unwilling or unable to give informed consent | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia Specific diagnosis of B-cell CLL An absolute lymphocytosis of > 5,000/uL Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes Bone marrow examination must at least a unilateral aspirate and biopsy; the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; overall cellularity must be normocellular or hypercellular Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (cluster of differentiation [CD]19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either kappa or lambda and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression Patients must have symptomatic and active intermediate or high-risk categories of the modified three-stage Rai staging system Not eligible: low risk, Rai stage 0, lymphocytes (L) in blood (> 5000/uL) and marrow (> 30%) only Intermediate risk, Rai stage I, L + enlarged lymph nodes (LN) Intermediate risk, Rai stage II, L + spleen and/or liver (LN + or -) High risk, Rai stage III, L + anemia (hemoglobin < 11 gm/dL) | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Lymphocytic Leukemia Mantle Cell Lymphoma Have histologically or cytologically confirmed CD5+/CD20+ B-Cell Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Meet the following CLL to participate in this study Absolute lymphocyte count > 5000/μL CD20+ and CD5+ Atypical cells representing < 55% on the peripheral smear Bone marrow lymphocytes ≥ 30% Or previous confirmed diagnosis of CLL/small lymphocytic lymphoma (SLL) with less than 5000/μl or less than 30% lymphocytes in BM CLL Patients are eligible if they have stage III or IV disease. Patients with stage 0, I or II disease will be eligible if they have evidence of active disease defined as one or more of the following signs/symptoms Documented weight loss of ≥ 10% over a six month period Febrile episodes of 38 degrees Celsius (100.5 degrees F) or greater for greater than 2 weeks without evidence of infection Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier May not be receiving any other investigational agents Known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide and/or thalidomide Prior desquamating (blistering) rash with thalidomide Neuropathy ≥ grade 2 Uncontrolled intercurrent illness including (not limited to) ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements Women currently pregnant or breastfeeding Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible History of another malignancy besides CLL or MCL who have been disease-free ≤ 3 years with exception of basal cell or squamous cell carcinoma of skin or carcinoma in situ of cervix or breast | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 0.0-999.0, Osteoarthritis The subject is scheduled to undergo elective total knee replacement at Duke University Hospital The subject has signed the written consent form Known allergy to ropivacaine or hydromorphone Known history of narcotic abuse or alcohol abuse Known history of chronic pain Known diagnosis of peripheral neuropathy or complex regional pain syndrome Significant impediment to physical therapy participation The surgery is a revision case Patient is undergoing bilateral Total Knee Replacement | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Patients should have completed their chemotherapy 3 months prior to start of treatment with lenalidomide and not more than 9 months prior to treatment initiation. 2. Patients with CLL/Small Lymphocytic Lymphoma (SLL) that achieve a complete or stable partial remission after combination of chemotherapy. Patients in complete remission need to have documentation of residual disease by immunophenotyping and/or PCR molecular testing. 3. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) status of 0-2. 4. Adequate renal and hepatic function (creatinine equal to or less than 2mg/dL total bilirubin equal to or less than 2). 5. Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; 2) or has not been naturally postmenopausal for at least 24 consecutive months (has NOT had menses at any time in the preceding 24 consecutive months). 6. FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control; one highly effective and one additional effective method AT THE SAME TIME at least 28 days before starting taking lenalidomide. 7. FCBP must also agree to ongoing pregnancy testing weekly for the first four weeks and then every 28 days while on therapy and at discontinuation of treatment. 8. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. 9. Age 18 and older. 10. Signed, written IRB-approved informed consent Known sensitivity to lenalidomide or thalidomide or it's derivatives 2. Known positivity for HIV or active hepatitis B or C. 3. Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide. 4. History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months. 5. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 6. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 7. Use of any other experimental drug or therapy within 28 days of baseline. 8. Concurrent use of other anti-cancer agents or treatments | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Lymphoma, Small Lymphocytic Leukemia, Lymphocytic, Chronic Patients with a diagnosis of CLL/SLL who have received at least one prior treatment regimen and have persistent disease (i.e. any evidence of active disease). Patients with a chromosome 17 abnormality or a p53 mutation of any type may be enrolled without having received prior treatment Patients must be 18 years of age or older Patient has an estimated or measured creatinine clearance ≥30 ml/min at study enrollment AST, ALT, total bilirubin < than 2.5 times the upper limit of normal WBC > 1.5; ANC >500; Plt >50,000 unless documented as due to disease ECOG performance status of 0-2 Voluntary written informed consent before performance of any study-related procedure not part of normal medical care Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for 2 weeks after administration of the study drug Male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 2 weeks after administration of study drug Female who is pregnant or lactating Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer, resected early stage prostate cancer not requiring systemic treatment or CIS of the cervix or fully treated early stage prostate cancer Significant cardiac or vascular events within 6 months: acute MI, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (NYHA class ≥ 2), uncontrolled cardiac arrhythmias, and disseminated intravascular coagulation Patients who are unable to refrain from taking acetaminophen Investigational agent within 14 days of enrolling on the study Patients unable or unwilling to refrain from antioxidants including vitamin A, vitamin C, vitamin E, lycopene, lutein, grape seed extract, pycnogenol, green tea extract, and the like Patients who have received a prior allogenic stem cell transplant and have at least 2.5% donor cells still evident on engraftment studies | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-50.0, Tuberculosis Subject is willing and able to give informed consent for participation in the study Male or Female, aged 18 to 50 years In good health BCG-naïve Screening elispot negative (less than 17 spot forming cells per million PBMC) for ESAT 6 and CFP 10 peptide pools Resident in or near Oxford for the duration of the study Female patient/subjects of child bearing potential must be willing to ensure that they practice effective contraception use during the study Subject has clinically acceptable laboratory results from Pre Study Screen Able (in the Investigators opinion) and willing to comply with all study requirements Willing to allow his or her General Practitioner to be notified of participation in the study Previous BCG vaccination Female subject who is pregnant, lactating or planning pregnancy during the course of the study Persons suffering from malignant conditions (e.g., lymphoma, leukaemia, Hodgkin's disease or other tumours of the reticulo-endothelial system), primary or secondary immunodeficiencies, HIV infection, or moderate/severe dermatological conditions Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed) Any history of severe allergic reaction or anaphylaxis in reaction to vaccination Administration of immunoglobulins or donation of blood products during the study or within the past 12 weeks Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of >42 units a week) Any on-going chronic illness requiring hospital specialist supervision Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study Subjects who have participated in another research study involving an investigational product in the past 12 weeks | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Hepatic Encephalopathy Must sign an Informed Consent Form In remission from past HE Appropriate birth control measures More than or equal to 18 years of age Must be potential for benefit from treatment Recent HE episodes Capable and willing to comply with all study procedures Participant has support network Significant medical conditions or Investigator decision not to the participant Allergies to the study drug or similar drugs Laboratory abnormalities Recent participation in another clinical trial Problems experienced in a previous HE trial Pregnant or at risk of pregnancy Recent alcohol consumption Active or latent bacterial or viral Infections Bowel issues Recent Active Cancer | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Hodgkin's Disease Lymphoma Histologic diagnosis of Classical Hodgkin lymphoma, confirmed by the department of hematopathology at MSKCC. Patients who have relapsed after an autologous stem cell transplant must have a biopsy after transplant to confirm relapsed Hodgkin's disease. Patients who have relapsed after an allogeneic transplant must also have a biopsy posttransplant Age > or = to 18 All patients must have PET avid measurable disease Last chemotherapy > or = to 4 weeks from the start of Bendamustine HCl Receiving no other treatment for HL Patients must have normal baseline cardiac function based upon echocardiogram or gated blood pool scan (MUGA) with an ejection fraction > or = to 50% Patients must have a serum creatinine of < or = to 1.5 mg/dl; if creatinine >1.5 mg/dl creatinine clearance must be >60 ml/minute Patients must have ANC>1000/mcl and Platelets>100,000/mcl Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's) Patients must be Hepatitis B surface antigen and Hepatitis B core antibody negative and Hepatitis C negative Patients with either parenchymal brain or lepto-meningeal involvement or more consecutive days of prednisone therapy prior to therapy Known pregnancy or breast-feeding Medical illness unrelated to HL, which in the opinion of the attending physician and principal investigator will preclude administration of chemotherapy safely. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix Relapse <6 months post allogeneic stem cell transplant | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia Chronic Lymphocytic Leukemia Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment. 2. Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time </= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia. 3. All patients must have a Zubrod performance status of </= 2. 4. All patients must be age >/= 18 years. 5. Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy. 6. All patients must have adequate renal function indicated by serum creatinine </=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST </= 2.5x ULN AND total bilirubin </= 2.5x ULN. 7. All patients must have a pre-treatment platelet count of >/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease. 8. All patients or appropriate surrogate must provide informed consent Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura. 2. Patients with active uncontrolled fungal, bacterial, or viral infection. 3. Patients who are pregnant or breast-feeding | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-65.0, Anaplastic Large Cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Marginal Zone Lymphoma Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Testicular Lymphoma Waldenstrom Macroglobulinemia Patients with CD20-expressing B cell NHL that is relapsed or refractory to standard therapy; CLL/SLL with peripheral blood leukemia/lymphoma cells and high-grade lymphomas (i.e., lymphoblastic lymphoma/Burkitt lymphoma) are excluded Patients must have received prior Rituxan Measurable disease; in the absence of lymphadenopathy, splenomegaly with defects or measurable extramedullary disease is acceptable; however, bone marrow involvement alone will not be included in the study Age >=18 years and <=65 physiologic years of age KPS >= 70% Life expectancy >= 12 weeks Serum creatinine =< 1.5 mg/dl Total WBC >= 3000/ul or absolute neutrophil count (ANC) >= 1000/ul Lymphocyte count >= 0.2 x 10^3/ul Platelet count >= 75,000/ul | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 7.0-999.0, Hereditary Elliptocytosis (HE) Hereditary Pyropoikilocytosis (HPP) > 7 years of age Consenting family members Anyone not meeting the above | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 2.0-17.0, Growth Hormone Deficiency Turner Syndrome Chronic Renal Failure Small for Gestational Age Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age [SGA] patients, based on RCP) Cases in which Saizen® is contra-indicated (based on local RCP) Children returning for consultation, who have not brought back their Easypod™ electronic self-injector Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukaemia Understand and voluntarily sign an informed consent form Age ≥18 years at the time of signing the informed consent form Able to adhere to the study visit schedule and other protocol requirements A confirmed diagnosis of B-cell CLL by NCI Working Group No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias (anemia or thrombocytopenia) is NOT considered a prior systemic therapy Radiation: Patients may have received prior radiation therapy restricted to ≤ 25% of functioning bone marrow. Patients must be ≥ 4 weeks since last treatment with radiation therapy Surgery: previous surgery is permissible. Patient must be ≥ 4 weeks since any major surgery Patients must have symptomatic disease requiring therapy. One or more of the following must be present to be eligible Symptomatic lymphadenopathy Hepatomegaly and/or splenomegaly Patients who fulfill any of the following are not eligible for admission to the study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Pregnant or lactating females. (Lactating females must agree not to breast feed while taking lenalidomide) Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Use of any other experimental drug or therapy within 28 days of baseline Patients previously or currently receiving treatment with other anti-cancer therapy for CLL Lymphoproliferative disease other than CLL (includes patients with prolymphocytic leukemia, mantle cell lymphoma, and those who have transformed to a more aggressive lymphoma, or Richter's syndrome) Known hypersensitivity to thalidomide The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs Any prior use of lenalidomide | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 0.0-999.0, Postoperative Pain Splenomegaly 15 cm or longer spleens Patient confirmation to join the study Normal sized spleens Patient denial | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting 1 of the following Binet stage C disease or stage B or A disease requiring treatment Binet stage B or A disease meeting ≥ 1 of the following B-symptoms (e.g., night sweats, weight loss ≥ 10% within the past 6 months, fevers > 38°C or 100.4°F for ≥ 2 weeks without evidence of infection) or constitutional symptoms (e.g., fatigue) Progressive lymphocytosis, defined as peripheral lymphocyte count > 5 x 10^9/L (i.e., > 50% increase over a 2-month period or doubling of peripheral blood lymphocyte count < 6 months) Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia Massive, progressive, or painful splenomegaly or hypersplenism Massive lymph nodes or lymph node clusters (> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy No 17p deletion by FISH No aggressive B-cell cancer, such as Richter syndrome | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Subjects must have a diagnosis of B cell CLL including Lymphocytosis of monoclonal B-cells co-expressing ≥ one B-cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood or lymph node AND Bone marrow with ≥ 30% mononuclear cells having the CLL/SLL phenotype 2. Measurable disease, and at least one of the IWCLL 2008 Guidelines "Indications for Treatment" as follows Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia Massive (i.e., >6 cm below the left costal margin) or progressive or asymptomatic splenomegaly Massive nodes (i.e., >10 cm in longest diameter) or progressive or symptomatic lymphadenopathy Progressive lymphocytosis with an increase of >50% over a 2-month period, or lymphocyte doubling time (LDT) of less than 6 months. LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) obtained at intervals of two weeks over an observation period of 2-3 months; patients with initial blood lymphocyte counts of less than 30,000 per microliter may require a longer observation period to determine the LDT. Also, factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g, infections) should be excluded Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy A minimum of any one of the following disease-related symptoms must be present Unintentional weight loss ≥10% within the previous 6 months Presence of > 55% prolymphocytes or Richter's transformation 2. Chemotherapy (e.g., purine analogues, alkylating agents, or corticosteroids), antibody therapy, immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of enrollment into protocol or at any time during the study 3. Ongoing toxicity from prior anti-neoplastic therapy 4. Untreated autoimmune hemolytic anemia or immune thrombocytopenia 5. Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis 6. Positive serologies for HIV1,2 or HTLV I,II 7. CMV disease with positive DNA PCR 8. Syphilis with positive VDRL 9. Acute Hepatitis A and C with positive serologies, and Hepatitis B, acutely or chronically infected based on CDC 10. Any illness or condition that in opinion of the investigator may affect safety of treatment or evaluation of any study's endpoints | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 0.0-999.0, Thyroid Cancer Lymph Node Metastasis Patient diagnosed to have differentiated thyroid carcinoma and has no detectable cervical lymphadenopathy Previous neck surgery, pregnancy and known hypersensitivity to the dye used | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 16.0-999.0, Chronic Lymphocytic Leukemia 16 years or older 2. Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month of steroids or chemotherapy) are eligible 3. Performance status of 3 or better (Appendix A) 4. Adequate renal and hepatic function (creatinine <2 mg%, bilirubin <2mg%). Patient with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman but upper limits for creatinine even under these circumstances would be creatinine < 3 mg% and bilirubin < 6 mg%. Patients with Gilbert's Syndrome may be entered on study with bilirubin 2-7 mg%.. 5. A signed informed consent in keeping with policies of the hospital None | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, B-Cell Chronic Lymphocytic Leukemia Male or female, at least 18 years old Signed informed consent Zubrod performance status of 0, 1, or 2 (Appendix C) Patients with CLL, CLL/PLL or PLL (prolymphocytic) who have achieved a clinical complete remission by NCI-WG with chemotherapy, eg., alkylating agents, fludarabine or chemoimmunotherapy but have documentation of residual disease by immunophenotyping showing: (a) a residual population of CD5 and CD19 positive cells that comprise ≥ 10% of the marrow mononuclear cell population; or (b) a residual population of CD5 and CD19 positive cells that comprise <10% of the marrow mononuclear cells and have a Kappa/Lambda ratio >6 or <.33 Patients with CLL who have achieved a partial remission (PR) or nodular partial remission (nPR) by NCI-WG after chemotherapy Creatinine, bilirubin, AST or ALT and alkaline phosphatase ≤2 x the upper limit of normal Active infection Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies Less than 2 months since prior chemotherapy Previous treatment with Pregnant or nursing women Patients on corticosteroids Uncontrolled autoimmune hemolytic anemia | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Head And Neck Cancer Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer 2. Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less 3. Part 2. Patient has a spouse or significant other with whom he/she resides 4. Part 2. Patient is able to vocalize well enough to complete the spousal interaction task 5. Parts 1 and 2. Patient and spouse are able to read and speak English 6. Parts 1 and 2. Patient and spouse are able to provide informed consent 7. Parts 1 and 2. Patient and spouse are at least 18 years of age 8. Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient None | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia Lymphoma Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Any stage disease Prior histological documentation of CD20+ CLL or SLL Has undergone autologous or syngeneic stem cell transplantation comprising high-dose therapy with peripheral blood stem cell rescue within the past 30-120 days No progressive disease after transplantation Has had stable disease or some degree of response to transplantation No history of CNS involvement Karnofsky performance status 70-100% Platelet count ≥ 50,000/mm³* (transfusion independent) ANC ≥ 1,500/mm³* | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment In accordance with Summaries of Product Characteristics (SPC) | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 5.0-999.0, Sickle Cell Disease Hemolytic Anemia Established Diagnosis of Hemolysis Sickle Cell Disease (e.g., HbSS, HbS/β-thalassemia, HbSC) Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH) 2. Age SCD participants: 5 years of age up to 19th birthday All other participants: 5 years of age and up (no age limit) Previous cardiac surgery 2. Known left ventricle dysfunction (i.e. shortening fraction < 28%) 3. Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diagnosis of B-cell CLL/SLL including Lymphocytosis of monoclonal B-cells co-expressing ≥ one B-cell marker (CD19, CD20, or CD23) AND CD5 in peripheral blood or lymph node AND Bone marrow with ≥ 30% mononuclear cells having the CLL/SLL phenotype. 2. Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, or inguinal regions. The size of the lymph nodes must be larger than 2x2 cm in the horizontal and perpendicular axes. 3. Intermediate or High risk, poor prognosis CLL/SLL 4. Indication for treatment as defined by the NCI Working Group Guidelines Massive (> 6 cm below the left costal margin) or progressive splenomegaly OR Massive lymph nodes or nodal clusters (> 10 cm in longest diameter) OR *Progressive lymphadenopathy OR Grade 2 or 3 fatigue OR Fever ≥ 100.5 degrees F OR Night sweats for greater than 2 weeks without documented infection OR Presence of weight loss ≥ 10% over the preceding 6 months OR Pregnant or nursing women. 2. Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study. 3. Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial. 4. Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. 5. Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD). 6. Participation in any investigational drug study within 28 days prior to ISF35 administration. (Patient must have recovered from all acute effects of previously administered investigational agents) 7. History of malignancy other than CLL within five years of registration, except patients with adequately treated basal, squamous cell carcinoma or localized cervical cancer. 8. Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis. 9. Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diagnosis of B-cell CLL/SLL including Lymphocytosis of monoclonal B-cells co-expressing ≥ one B-cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood or lymph node AND Bone marrow with ≥ 30% mononuclear cells having the CLL/SLL phenotype. 2. Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, or inguinal regions. The size of the lymph nodes must be larger than 2x2 cm in the horizontal and perpendicular axes. 3. Intermediate or High risk, poor prognosis CLL/SLL 4. Indication for treatment as defined by the NCI Working Group Guidelines Massive (i.e. > 6 cm below the left costal margin) or progressive splenomegaly OR Massive lymph nodes or nodal clusters (i.e. > 10 cm in longest diameter), or progressive lymphadenopathy OR Grade 2 or 3 fatigue OR Fever ≥ 100.5˚F or night sweats for greater than 2 weeks without documented infection OR Presence of weight loss ≥ 10% over the preceding 6 months OR Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period or an anticipated doubling time of less than 6 months Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and / or thrombocytopenia Pregnant or nursing women 2. Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study. 3. Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial. 4. Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification 5. Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD) 6. Participation in any investigational drug study within 28 days prior to ISF35 administration. (Patient must have recovered from all acute effects of previously administered investigational agents) 7. History of malignancy other than CLL within five years of registration, except patients with adequately treated basal, squamous cell carcinoma or localized cervical cancer. 8. Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis. 9. Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Leukemia Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following Peripheral blood absolute lymphocyte count > 5,000/mm³ Small to moderate-size lymphocytes with < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the following Predominant population of cells share B-cell antigens with CD-5 in the absence of other pan-T-cell markers (e.g., CD-3, CD-2) B-cell expresses either lambda or kappa light chains Surface immunoglobulin with low-cell surface density expression NOTE: *Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL Requires therapy, as indicated by ≥ 1 of the following Unintentional weight loss > 10% within the past 6 months | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken? | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-80.0, Chronic Lymphocytic Leukemia B-CLL confirmed according to NCI CLL relapsed or refractory to prior antineoplastic therapy Signs of progressive disease; at least one B symptoms lymphocyte doubling time of < 6 months symptomatic lymphadenopathy or splenomegaly cytopenias due to bone marrow failure) Age > 18 years, and less then 80 Serum ALAT, ASAT, bilirubin, creatinine < 2x upper limit of normal Life expectancy > 6 months Active bacterial or viral infection Hypersensitivity to humanized monoclonal antibodies Concurrent antineoplastic treatment for CLL or other malignant disease Absolute neutrophil count < 1.5 K/ | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma A diagnosis of CLL or SLL based on iwCLL diagnostic criteria Prior therapy for CLL (no limit on number of prior regimens) Patients requiring therapy, based on at least one of the iwCLL criteria years of age or older Performance status ECOG 0, 1, or 2 An estimated or measured creatinine clearance ≥30 ml/min at study enrollment AST, ALT, and total bilirubin ≤ 2.5 times the upper limit of normal, unless due to CLL/SLL Female subject who is either post-menopausal or surgically sterilized or male or female subject willing to use an acceptable method of birth control for the duration of the study therapy and for 2 weeks after study therapy completion Female subject is pregnant or lactating Patient has received other investigational drugs for this disease within 14 days of enrollment Patient with known HIV prior to enrollment Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer or CIS of the cervix or early stage prostate cancer not requiring systemic treatment Patients who underwent allogeneic stem cell transplant and have at least 2% donor cells engrafted will be excluded Significant cardiac or vascular events within 6 months: acute MI, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (NHYA class ≥ 2), uncontrolled cardiac arrhythmias Known severe hypersensitivity to perifosine or any component of the formulation Life expectancy less than six months due to co-morbid illness Active autoimmune hemolytic anemia or immune thrombocytopenia, requiring current steroid therapy | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 0.0-999.0, Neuroblastoma Bone Marrow, Sympathetic Nervous System Diagnosis of NB as defined by international i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System,57 i.e., stage 4 with (any age) or without (>365 days of age) MYCN amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified stage 4S Patients must have a history of tumor progression or persistent disease or failure to achieve complete response following standard therapy Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy Disease staging approximately within one month of treatment Human anti-mouse antibody (HAMA) titer <1000 Elisa units/ml if applicable Available autologous stem cells: ≥2 x 106 CD34+ cells/kg Adequate cardiac function as measured by echocardiogram Eligible NK donor Signed informed consent indicating awareness of the investigational nature of this program. Donor Patients with CR/VGPR disease Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity > or = to grade 3 except for hearing loss, alopecia, anorexia, nausea, hyperbilirubinemia and hypomagnesemia from TPN, which may be grade 3 ANC should be >500/uL; platelet count >25K/uL History of allergy to mouse proteins Active life-threatening infection HAMA titer >1000 Elisa units/ml Inability to comply with protocol requirements Donor Cardiac risk factors precluding ability to undergo leukopheresis Concurrent malignancy or autoimmune disease Donor is pregnant | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Lymphadenopathy patients 18 years or older 2. Patients in which EBUS is indicated based on the suspicion of either benign or malignant disease in mediastinal and/or hilar lymph nodes. This will patients who are in the hospital patients under 18 years or younger | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Patients undergoing routine blood draws as part of their ongoing follow-up for Chronic Lymphocytic Leukemia (CLL) at the Norris Cotton Cancer Center of DHMC Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for CLL or other disease process within the past 6 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-75.0, Chronic Lymphocytic Leukemia Age 18-75 years at the time of signing the informed consent form. 2. Disease: CLL in relapse, after failing conventional chemo-antibody combination therapy; CLL patients who failed to achieve CR with frontline conventional chemo-antibody; CLL patients with 17p deletion; CLL in Richter's. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Donor: HLA compatible related (HLA-A,-B,-DRBI matched or with one-antigen mismatched) or HLA compatible unrelated. 5. ECOG performance status of </= 2 at study entry 6. FEV1, FVC and DLCO >/= 40%. 7. Left ventricular EF > 40% with no uncontrolled arrhythmias or symptomatic heart disease. 8. Serum creatinine </= 1.6 mg/dL. Serum bilirubin < 1.6 mg/dL. 9. SGPT < 2x upper limit of normal. 10. Voluntary signed, written IRB-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 11. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 3 weeks prior to treatment in this study. 12. Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast. 13. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 days prior to study entry. 14. Disease must be chemosensitive (ie, patients must have PR or better based on CT Scans, PET Scan, and bone marrow biopsy). 15. Patients suspected to have Richter's transformation (such as elevated LDH) and/or who are PET positive, should have a lymph node biopsy to assess histological status of the disease 16. Patients must be off of alemtuzumab for 6 weeks prior to consenting Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Use of any other experimental drug or therapy within 28 days of baseline. 5. Known hypersensitivity to thalidomide, lenalidomide, bendamustine, fludarabine. For patients will unrelated donors: Known hypersensitivity to thymoglobulin. 6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 7. Concurrent use of other anti-cancer agents or treatments. 8. Known positive for HIV or infectious hepatitis, type A, B or C. 9. Sinuses should be evaluated by either CT neck or CT sinuses to infections 10. Deep-vein thrombosis or pulmonary embolism within 3 months of study entry. 11. History of serious infection requiring hospitalization within the last 3 months of consenting | 2 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-120.0, Leukemia Stored frozen viable cells from patients with chronic lymphocytic leukemia treated on clinical trial ECOG-2997 Not specified PRIOR Not specified | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-75.0, Hepatic Encephalopathy Diagnosis of hepatic cirrhosis based on biopsy, clinical and/or radiological findings Stable HE (chronic): On daily lactulose for more than 6 months without hospitalization for HE within 3 months of enrollment Treated with lactulose on a daily basis, with restoration of mental status to baseline Lives with an adult individual who is willing to serve as a full-time caregiver Able and willing to give informed consent Use of antibiotics, including rifaximin Patient without an adult caregiver Pre-existing focal neurological deficits, seizures or other indication of structural neurological disorder Actively abusing illicit drugs or alcohol | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-90.0, Lung Cancer Sarcoidosis Tuberculosis years old and older Hilar and/or mediastinal lymphadenopathy (> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography)) Uncontrolled coagulopathy Refusal to sign informed consent | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage I Small Lymphocytic Lymphoma Stage II Chronic Lymphocytic Leukemia Stage II Small Lymphocytic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Small Lymphocytic Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Small Lymphocytic Lymphoma Patients must have a confirmed diagnosis of CLL/SLL Patients with previously untreated cluster of differentiation (CD)20+ CLL/SLL must have either Rai stage III/IV disease or be Rai stage I/II with evidence of disease activity as defined by the National Cancer Institute (NCI) 1996 guidelines; patients with SLL must be Stage III or IV per Ann Arbor staging system Patient must have consented to participate in the study and signed and dated an appropriate institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Patient must have an anticipated (untreated) survival of at least 3 months Female patient of childbearing potential has a negative serum pregnancy test beta-human chorionic gonadotropin (hCG) within 2 weeks prior to receiving the first dose of vorinostat Female patient is either post menopausal, free from menses for >= 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with Visit 1 Male patients not sterilized must be willing to use adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with Visit 1 Absolute Neutrophil Count (ANC) >= 1,500/mcL Platelets >= 100,000/mcL Patients who have received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment prior to study entry for CLL/SLL; patients who have received systemic steroids within 1 week of study entry are excluded, except patients on maintenance steroid therapy for a noncancerous disease Patients with active hemolysis Patients must not require sustained transfusion support of blood products Patients who have undergone treatment with either stem cell or bone marrow transplant Patients with active obstructive hydronephrosis Patients with evidence of any significant systemic illness, active hepatitis B infection, active viral hepatitis infection or other active infection at the time of study entry Patients with New York Heart Association class III or IV heart disease symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other serious illness, such as acute or chronic graft versus host disease, that would preclude evaluation Patients with congenital long QT syndrome and patients taking antiarrhythmic medicines or other medicinal products that lead to QT prolongation will only be eligible if their baseline corrected QT (QTc) prolongation is =< 500 msec Patients with known human immunodeficiency virus (HIV) infection Patients who are pregnant or nursing | 1 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Hairy Cell Leukemia One of the following: 1. Patients who previously received CAT-3888 and did not have unacceptable toxicity 2. Patients who received CAT 8015 in study CAT 8015-1001 and have progression of disease or relapse. These patients must be considered off-study for CAT-8015 protocol specified follow-up Patient must have histopathological evidence of HCL as confirmed by the Laboratory of Pathology, NCI. At least one of the following indications for treatment: 1. Neutropenia (absolute neutrophil count (ANC) less than 1000 cells/microL). 2. Anemia (hemoglobin (Hgb) less than 10 g/dL). 3. Thrombocytopenia (platelet (Plt) less than 100,000/microL). 4. Absolute lymphocyte count of greater than 5000 cells/microL 5. Symptomatic splenomegaly. 6. Enlarging lymph nodes greater than 2cm. Patient must have had at least 2 prior systemic therapies. There must have been at least 2 prior courses of purine analog, or 1 if the response to this course lasted less than 2 years, or if the patient had unacceptable toxicity to purine analog. Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, unless due to potentially reversible active uncontrolled infection. Patient must be greater than or equal to 18 years old. Patient can understand and give informed consent. Patient must have adequate liver and renal function, as defined by the following 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5-times the upper limits of normal. 2. Albumin greater than or equal to 3.0 g/dL. 3. Total bilirubin less than or equal to 2.2 mg/dL. 4. Creatinine less than or equal to 1.4 mg/dL or creatinine clearance greater than or equal to 50 mL/min. Patient must agree to using adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of the study Patients who are pregnant or nursing. A negative pregnancy test (urine or serum) must be documented within one week prior to starting BL22 in women of child-bearing potential. Patient has developed antibody titer that neutralizes greater than 75% of the activity of 1 microg/mL of BL22 using a bioassay. Patients who had systemic cytotoxic chemotherapy, immunotherapy, recombinant anti-CD22 immunotoxin (ie, CAT-8015, BL22, or LMB-2) or systemic steroid (with the exception of stable doses of Prednisone less than or equal to 20 mg/day) treatment within 4 weeks of enrollment. Patients receiving a limited number of doses (less than 5) of steroid for non-treatment reasons (eg, allergy prophylaxis connected with medical testing) may not receive any steroid within one week of enrollment and may not have had any evidence of disease response to steroid. Subjects who are receiving steroids for other conditions (e.g., autoimmune disorders) are eligible, as long as there is no increase in the dose or change in steroid type within 1 week of treatment. Subjects who are using a chronic steroid must wait for 4 weeks before starting the trial. Patient had monoclonal antibody therapy (with the exception of BL22 or CAT-8015 or LMB-2) within 4 weeks of enrollment. Patient is receiving any other investigational agent. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients who discontinued from CAT-8015 or BL22 studies due to toxicity or dose-limiting toxicity. Dose limiting toxicity to CAT-8015 | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-999.0, Isolated Mediastinal Lymphadenopathy Sarcoidosis Tuberculosis Lung Cancer Lymphoma Consecutive patients with undiagnosed mediastinal lymphadenopathy (>1cm in short axis) on CT or PET-CT scan for whom pathological evaluation is clinically indicated Patients without informed consent, those with anterior mediastinal lesions or with contra-indications to EBUS or mediastinoscopy will be excluded | 0 |
This is a 57-year-old gentleman with CLL and large cell transformation. He presented with his disease back in [**10/2119**] with an elevated white count and LDH. He was without any splenomegaly or any cytopenias at that time. He did have some bulky lymphadenopathy. He then completed four cycles of FCR therapy, which he completed back in 09/[**2119**]. He had an excellent response to therapy and was monitored off treatment for approximately two years. He then presented in [**7-/2122**] with a rising white count, approximately 50% lymphocytes, and a mildly elevated LDH. He also had some mild worsening palpable lymphadenopathy. He then received four cycles of PCR, but did not have much in the way of response and his treatment regimen was switched to R-CVP of which he received two cycles. He did again not have a significant response, though continued to have an excellent performance status, and he was ultimately switched to Campath therapy. He did have resolution of his lymphocytosis, and his white count has come down nicely, but did not have much in the way of response in terms of reducing his bulky lymphadenopathy. He then eventually had developed an enlarging left cervical node which was biopsied and | eligible ages (years): 18.0-120.0, Lymphocytic Leukemia Diagnosis of CLL manifested by minimum threshold peripheral lymphocyte count of > 5 x 10^9/L (CLL variant) OR palpable adenopathy >= 1cm or clinically palpable splenomegaly (SLL variant); AND immunophenotypic demonstrations of a population of B lymphocytes (as defined by CD19+) which are monoclonal (by light chain exclusion) CLL will be diagnosed if these cells have >= 3 of the following characteristics: CD5+, CD23+, dim surface light chain expression, dim surface CD20 expression, AND FISH analysis is negative for IGH/CCND1 and/or immunostaining is negative for cyclin D1 expression to mantle cell lymphoma Previous treatment for CLL Progressive disease: symptomatic CLL (weight loss>10% within 6 months, extreme fatigue, fevers>38.5 C, drenching night sweats without evidence of infection) OR evidence of progressive bone marrow failure (hemoglobin<11g/dL, platelet count<100 x 10^9/L) OR massive (>6 cm below left costal margin) or progressive palpable splenomegaly OR massive (>10 cm) or measurable and progressive lymphadenopathy Please contact study investigator and/or consult protocol document for specific details on laboratory CD52 expression by CLL cells Willing to provide mandatory biospecimen samples for research studies as required by the protocol Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Willingness to return to the enrolling institution for follow-up ECOG Performance Status (PS) 0, 1, or 2--Exceptions: Grade 3 allowed if caused by CLL and not other co-morbidities Provide informed written consent Life expectancy >= 3 months Any of the following comorbid conditions: NYHA class III-IV heart disease, recent myocardial infarction (< 6 months prior to registration), uncontrolled infection, infection with the human immunodeficiency virus (HIV/AIDS), serological evidence of active hepatitis B infection (HBsAg or HBeAg positive) or positive hepatitis C serology, as further severe immunosuppression with this regimen may occur Evidence of active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia Other active primary malignancy requiring treatment or that limits survival to =< 2 years Any major surgery =< 4 weeks prior to registration Concurrent investigational drug therapy Any of the following: pregnant women,nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, abstinence, etc.) Concomitant use of the following CYP3A4 strong inhibitors: Clarithromycin, Nefazodone, Telithromycin, Aprepitant, Indinavir, Nelfinavir, Diltiazem, Borisonazole, Itrazonazole, Ritonavir, Erythromycin, Ketoconazole, Saquinavir, Fluconazole (may be used if drug levels can be monitored) Patients with any known bleeding diathesis (any congenital bleeding disorder that affects platelet function and/or coagulation including von Willebrand's Disease) Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air Receiving anticoagulant therapy | 2 |
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