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60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 40.0-85.0, Glaucoma Open-Angle Primary Cataract General 1. Male and female patients, from 40 to 85 years of age, inclusive. 2. Patient is able and willing to attend scheduled follow-up examinations as per routine care for 2 year post-operatively. 3. Patient is able to understand the information sheet and give informed consent. for the study eye: 4. An operable age-related cataract with BCVA of 6/9 or worse that is eligible for phacoemulsification. 5. A diagnosis of POAG or pigmentary glaucoma treated with hypotensive medications (eye drops for glaucoma). 6. A previously documented unmedicated intraocular pressure of > 21 mmHg (i.e. IOP > 21 mmHg prior to the commencement of glaucoma treatment). 7. An optic nerve appearance characteristic of glaucoma with either: 1. visual field loss (no worse than -12dB) identified on examination using Humphrey 24-2 SITA standard, or 2. (in patients where the VF exam is not confirmatory for glaucomatous defect) OCT retinal nerve fibre layer imaging supporting the ophthalmoscopy findings indicating a diagnosis of mild glaucoma. (If OCT findings are not confirmatory of glaucoma and both the visual field and the OCT are normal, the patient should not be enrolled). 8. Shaffer grade ≥2 in all four quadrants on gonioscopy. 9. Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair surgical access to the ciliary processes Diagnosis of Primary angle closure glaucoma. 2. Any diabetic retinopathy. 3. Previous history of Central Serous Retinopathy or Cystoid Macular Oedema in either eye. 4. Congenital or developmental glaucoma. 5. Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, lens-induced, steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure). 6. Previous trabeculectomy, tube shunts, or any other prior subconjunctival filtration or cycloderstructive surgery. 7. Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors should not be greater than 33%). 8. Patients with advanced glaucoma or any patient where the risk to the patient of a washout of ocular hypotensive medications (eye drops for glaucoma) is assessed as unacceptable (i.e. where there may be a risk of damage to vision if treatment is stopped for the washout). 9. Best corrected visual acuity worse than 6/36 in the fellow eye (i.e. not the eye undergoing the study intervention). 10. A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the study eye. 11. Previous vitreo-retinal surgery. 12. Previous corneal surgery or clinically significant corneal dystrophy, e.g. Fuch's dystrophy (>12 confluent guttae). 13. Unclear ocular media preventing visualization of the fundus or anterior chamber angle. 14. Degenerative visual disorders such as wet age-related macular degeneration. 15. Clinically significant ocular pathology other than cataract and glaucoma. 16. Clinically significant ocular inflammation or infection within 1 month prior to screening. 17. Presence of extensive iris processes that obscure visualization of the trabecular meshwork. 18. Uncontrolled systemic disease that in the opinion of the investigator would put the patient's health at risk and/or prevent the patient from completing all study visits. 19. Current participation or participation within the past 30 calendar days in another investigational drug or device clinical trial (which includes the fellow eye). 20. Pregnant or nursing women, or women of child bearing age planning pregnancy or not using medically acceptable contraceptives. 21. Unwilling or unable to give informed consent/unwilling to accept randomisation. 22. Unwilling or unable to return for scheduled protocol visits. 23. Any not met | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Gastritis, Atrophic Helicobacter Pylori Infection Intestinal Metaplasia Gastritis above 18 years of age agreed to participate in the study patients with dyspepsia in accordance with Rome those taking PPIs or antibiotics three weeks prior invitation severe uncontrolled coagulopathy prior history of gastric surgery those pregnant or nursing females | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Chronic Hepatitis C Ages 18 to 75 Unlimited gender Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015) No hormones and / or immunosuppressants and other hepatoprotective drugs Sign a written informed consent Combined with other hepatitis virus (HBV, HDV) infections Immune liver disease HIV infection long-term alcohol and / or other liver damage drugs mental illness Evidence of liver tumor (liver cancer or AFP> 100 ng / ml) Decompensated cirrhosis Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up There are hormones and / or immunosuppressants and other hepatoprotective drugs | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Acute-On-Chronic Liver Failure Hepatic Encephalopathy Liver transplant recipients who meet all of the following will be enrolled 1. Pre transplant liver failure: Total bilirubin over 171μmol/L and prothrombin activity (PTA)<40%; 2. Overt hepatic encephalopathy(HE): Grade II or higher HE according West Haven classification; 3. HE associated with acute liver failure (Type A) or cirrhosis complicated with portal hypertension and/or portal systemic shunts (Type C) Patients with a previous history of kidney-related diseases and glomerular filtration rate <30 millilitre per minute; 2. Patients with acute renal failure need CRRT before transplantation; 3. Patients newly developed acute renal failure need CRRT at the time of randomization; 4. Retransplantation or multiple-organs transplantation; 5. Any ischemic or hemorrhagic stroke co-morbidity; 6. Hemodynamic instability requiring fluid resuscitation or very high dose of vasopressors; 7. Extremely moribund patients with an expected life expectancy of less than 24 hours | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Coronavirus Severe Acute Respiratory Syndrome Outpatient trial: 1. Symptomatic and laboratory-confirmed diagnosis of COVID-19. 2. Age ≥18 years. 3. High risk: either age ≥70 or one of the following: male; obesity (BMI ≥30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes. 4. Within 7 days (ideally 72 hours) of diagnosis, or worsening clinically General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation. 2. Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitor, azole antifungal, or macrolide antibiotic (except azithromycin). 3. ASA: allergy; high risk of bleeding, current or planned use of other anti-thrombotic drugs (e.g., P2Y12 inhibitors, direct oral anticoagulants, vitamin K antagonists, heparins) Inpatient trial: 1. Symptomatic and laboratory-confirmed diagnosis of COVID-19. 2. Age ≥18 years. 3. Within 72 hours (ideally 24 hours) of admission, or worsening clinically General: advanced kidney disease; advanced liver disease, pregnancy (known or potential) or lactation, already ventilated for >72 hours. 2. Interferon-ß: known monoclonal gammopathy, history of severe depression/anxiety. 3. Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin). 4. ASA and rivaroxaban: allergy; high risk of bleeding; estimated GFR <15 ml/min; current or planned use of P2Y12 inhibitors or therapeutic doses of anticoagulants* (e.g., direct oral anticoagulants, vitamin K antagonists, heparin, LMWH), current or planned use of strong inhibitors of both CYP 3A4 and P-gp (e.g., lopinavir/ritonavir, carbamazepine, ketoconazole). *Note that prophylactic doses of anticoagulants can be used in patients who are randomized to control | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, MAGEC Rod Patients that have been treated with, and still have, a MAGEC rod Patients that do not have a MAGEC rod implant | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Prevention of Esophageal Varices NASH - Nonalcoholic Steatohepatitis Cirrhosis Each subject must meet all of the following to be enrolled in this study: 1. Is male or female, ≥ 18 and ≤ 75 years of age at the time of Screening. 2. Is willing and able to provide written informed consent prior to the initiation of any study-specific procedures. 3. Has evidence of portal hypertension, with either one of the following: 1. platelet count <150,000/mm3 2. documented HVPG measurement >6 mmHg OR 3. at least two of the following spleen size ≥14 cm (documented by ultrasound, MRI, or CT scan) abdominal collateral circulation (documented by ultrasound, MRI, or CT scan or physical examination, ie, caput medusae) documented liver transient elastography (eg, FibroScan) ≥20 kPa. 4. Has a history confirming nonalcoholic steatohepatitis (NASH) cirrhosis, with at least one of the following There is a historical liver biopsy showing cirrhosis with steatohepatitis. There is no evidence for a competing etiology for the cirrhosis There is a historical liver biopsy showing steatohepatitis, and there is evidence of cirrhosis from clinical or imaging data or a second liver biopsy showing cirrhosis without all features of NASH (as the histological NASH lesions may have burnt out). There is no evidence for a competing etiology. There is at least 1 co-existing metabolic comorbidity at Screening: obesity (with either body mass index [BMI] ≥30 kg/m2 or waist circumference ≥102 cm [40 in, men] or ≥88 cm [35 in, women], or by ethnically appropriate cutpoints); hypertension (either on anti hypertensive drug therapy for at least 1 year or systolic/diastolic blood pressure (BP) >140/80 mm Hg); Type 2 diabetes (glycated hemoglobin [HbA1c] ≥6.5%, or on anti-diabetic medication for at least 1 year); or dyslipidemia (triglycerides ≥150 mg/dL or on drug therapy for hypertriglyceridemia for at least 6 months; high-density lipoprotein cholesterol ≤40 mg/dL [men] or ≤50 mg/dL [women]) to corroborate a diagnosis of nonalcoholic fatty liver disease (NAFLD) There is a historical liver biopsy showing cirrhosis with steatosis but not steatohepatitis. There is no evidence for a competing etiology. There are at least 2 co-existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD There is a historical liver biopsy showing steatosis but now with cirrhosis either by clinical examination, imaging, or biopsy. If there is a current biopsy, it does not show evidence of steatosis or steatohepatitis as histological lesions may have burned out. There is no evidence for a competing etiology. There are at least 2 co existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD For patients without a historical liver biopsy with slides available for review by the central study pathologist, a screening liver biopsy is required. Note: All liver biopsy blocks and/or slides for assessments (including those from historical biopsies) will be reviewed by the central study pathologist while the subject is in Screening, and must meet definitions for diagnosis of either Definitive cirrhosis or Probable cirrhosis. Results from the central study pathologist must be available before the subject is randomized. 5. Absence of hepatocellular carcinoma (HCC) by valid imaging (eg, ultrasound, CT scan, or MRI) within 6 months prior to randomization. If no such imaging result is available, then ultrasound imaging should be performed as part of standard of care. 6. Patients with diabetes mellitus can be enrolled, if they are adequately controlled on a stable dose or doses of antidiabetic medication(s) for at least 3 months before Screening, and their screening HbA1c is ≤9.5%. 7. Patients on vitamin E or pioglitazone can be enrolled if they are on a stable dose and regimen for at least 3 months before screening, and the dose is expected to be held constant during the trial. 8. Patients on a statin can be enrolled if they are on a stable regimen for at least 3 months before Screening, and expected to be held stable during the trial. 9. Is not pregnant and must have a negative serum pregnancy test result prior to randomization. 10. Is of non-childbearing potential or if a fertile man or woman participating in heterosexual relations, agrees to use two acceptable means of contraception (ie, 2 effective methods of contraception, one of which must be a physical barrier method [eg, male or female condom, diaphragm] when combined with a highly effective method of contraception [ie, a method with a failure rate of <1% per year when used consistently and correctly]) throughout his/her participation in this study and for 90 days after discontinuation of study treatment. Highly effective forms of contraception combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (such as oral, intravaginal, transdermal) methods Subjects meeting any of the following will be excluded from the study: 1. Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper gastrointestinal (GI) esophagogastroduodenoscopy (EGD) exam conducted during Screening. Patients with portal hypertensive gastropathy could be enrolled. 2. History of hepatic cirrhosis decompensation including any episode of variceal bleeding, ascites not controlled by medication, spontaneous bacterial peritonitis or overt hepatic encephalopathy (West Haven grade ≥2 as assessed by the principal investigator), OR develops signs of hepatic cirrhosis decompensation during Screening. 3. Known or suspected abuse of alcohol (>20 g/day for women or >30 g/day for men [on average per day]), as per medical history. Significant alcohol consumption is defined as more than 20 grams per day in females and more than 30 grams per day in males. On average, a standard drink in the United States is considered to be 14 grams of alcohol, equivalent to 12 fluid ounces of regular beer (5% alcohol), 5 fluid ounces of table wine (12% alcohol), or 1.5 fluid ounces of 80 proof spirits (40% alcohol). 4. Alcohol dependence (ie, a score >8 on the Alcohol Use Disorders Identification Test) 5. Narcotics or any other drug abuse or dependence in the last 5 years 6. Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt procedure 7. Documented causes of liver disease other than NASH, including but not restricted to Viral hepatitis, unless eradicated at least 3 years prior to Screening acute hepatitis A infection (presence of hepatitis A immunoglobulin M [IgM] at Screening) positive hepatitis B surface antigen positive hepatitis C virus (HCV) ribonucleic acid (to be performed prior to randomization in case of positive HCV antibody) Documented drug-induced liver disease Alcoholic liver disease Autoimmune hepatitis Wilson's disease Hemochromatosis | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 21.0-99.0, Nephrolithiasis, Uric Acid Idiopathic uric acid nephrolithiasis, with last stone analysis showing that stone has >90% uric acid in composition Age >21 years Any gender, race/ethnicity (from weight loss), but weight <165 Kg (to fit into MR instrument); eGFR>60ml/min/1.73 m2 Bariatric surgery, chronic diarrhea, recurrent UTIs current insulin use use of a thiazolidinedione in past 2 years contraindication to thiazolidinedione use (liver dz, pedal edema, CHF NYHA class III/IV, no contraception) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, COVID COVID 19 confirmed patients <18 years Pregnant women Asymptomatic and normal x-ray findings subjects | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Orthostatic Hypotension Patient at Central Texas Rehabilitation Hospital in Austin, Texas 2. Age 18 years or older 3. Patient presents with orthostatic hypotension defined as transitions from sit to stand using a threshold of drop of at least 15 mmHg for SBP or at least 7 mmHg for DBP. 4. Aquatic therapeutic exercise is included in patients plan of care. 5. Signed informed consent Contraindication for aquatic physical therapy including but not limited to open wound that cannot be safely covered with a waterproof dressing, diarrhea, fever or know contagious infection. 2. Unable to safely maintain standing position for 2 min with or without assistance to measure vitals in pool and land. 3. Change in blood pressure medication or medical status between pool and land data collection | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Hepatic Encephalopathy Cirrhosis (standard criteria) and either no evidence of overt hepatic encephalopathy (OHE) or prior OHE or current grade II OHE Grade III or IV OHE, Mini-mental state examination score ≤25 (suggestive of dementia); alcohol or illicit drug use within 3 months; current use of benzodiazepines, antiepileptics or psychotropic drugs; color blindness; severe vision impairment (blindness, macular degeneration) | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Cirrhosis, Alcoholic Progression Liver Diseases Decompensated Cirrhosis Clinical suspicion of cirrhosis supported by biochemistry and ultrasound or other imaging techniques Cirrhosis of any etiology Informed written consent People where the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging Withdrawal of informed consent or no informed consent Persons eligible for where the investigational program is delayed or not initiated within six months after the diagnosis of suspected cirrhosis | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Hepatic Encephalopathy All patients of 18-80 years admitted to Aga Khan University Hospital 2. With Chronic liver disease: Chronic liver disease will be defined based on ultra-sonographic evidence of chronic liver disease including shrunken liver, dilated portal vein, splenomegaly. 3. With Hepatic encephalopathy; Hepatic encephalopathy will be defined as the onset of disorientation or asterixis according to The International Society for Hepatic Encephalopathy and Nitrogen Metabolism consensus and will be assessed using HESA score 4. Presence of first degree relative for consent (Next of kin) Allergy to PEG 2. Bowel obstruction or perforation diagnosed clinically or on Xray 3. Major psychiatric illness; on benzodiazepines 4. Treated with locally acting antibiotics (rifaximin) in the previous 7 days; 5. Active gastrointestinal tract bleeding 6. Acute Liver failure:defined as coagulopathy (international normalized ratio >1.5) with any degree of AMS in the absence of underlying chronic liver disease (CLD) 7. Female patients if pregnant or lactating | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Heart Failure Male or female Age 18 and older Active on the transplant list Donor organ with Antibody and NAT (nucleic acid test) positive for HCV HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team Participants co-infected with HIV Donor previously treated with an NS5a containing regimen (if treatment history of donor known) Known allergies or hypersensitivity to DAA or ribavarin Pregnancy and/or actively breastfeeding | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Castration-Resistant Prostate Carcinoma Metastatic Prostate Adenocarcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Histologic/cytologic documentation of prostate adenocarcinoma Adequate archival tumor specimen or archival slides must be available to be tested as part of the trial screening (most recent metastatic site biopsy preferred, but primary prostate biopsy allowed if metastatic biopsy is not available or inadequate. A new biopsy is not required for enrollment in the trial as long as sufficient archival tissue is available). Due to significant variability between tests, results from an existing targeted next-generation exome sequencing test may not be used for this trial Progressive disease must be demonstrated at study entry while the patient is on continuous androgen deprivation therapy (ADT) or status post orchiectomy. Progressive disease is defined as one or more of the following PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 1.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy (>=4 weeks since last flutamide, bicalutamide or nilutamide, apalutamide or darolutamide) Radiographic progression per Response Evaluation in Solid Tumors (RECIST) 1.1 for soft tissue lesions and/or per Prostate Cancer Working Group 3 (PCWG3) for bone lesions Measurable or non-measurable disease No prior therapy for metastatic castration-resistant prostate cancer, defined as a treatment given for prostate cancer with radiographically-detectable metastasis and a serum testosterone level less than 50 ng/dl (1.73 nmol/L) at the time of registration >= 2 weeks or 5 half-lives (whichever is shorter) since prior therapy with flutamide, dutasteride, bicalutamide, niltamide, finasteride, aminoglutethimide, estrogens, cytoproterone, chemotherapy, abiraterone, apalutamide, or darolutamide >= 4 weeks or 5 half-lives (whichever is shorter) since any prior investigational therapy >= 4 weeks since a major surgery or radiation | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-100.0, Malnutrition Cirrhosis, Liver Patients diagnosed with liver cirrhosis Patients with cognitive impairment or major psychiatric disorder Lack of consent from the patient for in the study Any patient who is not suitable based on the researcher's own judgement | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 55.0-999.0, Chronic Subdural Hematoma Must be 55 years of age or greater Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation Failure to obtain consent Vulnerable study population Any need for chronic anticoagulation Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma Glasgow Coma Scale (GCS) less than 8 | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-99.0, Liver Diseases Humans Progression Carcinogenesis Fatty Liver Disease Hepatitis C Hepatitis B Hepatocellular Carcinoma Liver Cirrhoses Treatment Outcome Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation Age younger than 18 or older than 99 years | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Portosystemic Collateral Veins • Age between 18 and 70 years old Patient with documented liver cirrhosis undergoing either primary or secondary prophylactic variceal eradication Liver cirrhosis with Child-Pugh score A and B • Age less than 18 years Have contraindications to computed abdominal CT-angiography (e.g. allergy to all suitable contrast agents, renal failure) Patients with history of recent significant bleeding varices Previous history of variceal ligation, sclerotherapy, and TIPS operation Patients with isolated gastric varices Patients with HCC or other malignancies End-stage liver disease (Child score more than 9) Patients with malignant portal vein thrombosis Patients with non-cirrhotic portal hypertension Patients refuse to participate in the study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Cirrhosis Due to Hepatitis B Cirrhosis Due to Hepatitis C Gastroesophageal Varices HBV-related or/and HCV-related liver cirrhotic patients based on pathology or clinical diagnosis Antiviral therapy Male or Female ES showed the presence of esophageal and gastric varices and / or red signs Child-Pugh < 10, and meld < 29 Signature of informed consent • Used antibiotics, prebiotics, probiotics and proton pump inhibitors within 2 weeks Any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heart failure, atrioventricular block, sinus bradycardia (HR < 50 / min), cardiogenic shock, hypotension (SBP < 85mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease Unstable high blood pressure and long-term engagement in driving Any malignancy that affects survival, excluding the cured Patients with portal thrombosis PT extension greater than 4 seconds, PLT<30×10^9/L Pregnant and lactating patients History of surgery for portal hypertension；History of prior EVL (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt Patients with severe diseases of vital organs such as heart, lung, kidney, brain, blood and nervous system Allergic to carvedilol and berberine | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Cirrhosis Portal Hypertension Surgery Acute-On-Chronic Liver Failure Non-Cirrhotic Portal Hypertension Male or female adult (≥18 years) patient With or without liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and radiological signs) Or Non-cirrhotic portal hypertension Non-pregnant, non-lactating females Ability to understand the patient information and to personally sign and date the informed consent to participate in the study The patient is co-operative and available for the entire study Provided written informed consent Indication for surgical intervention Pregnant or lactating females Patients undergoing surgery as form of palliative cancer therapy Presence or history of severe extra-hepatic diseases HIV-positive patients Previous liver or other transplantation Patients with acute or subacute liver failure without underlying cirrhosis Patients who decline to participate Physician´s denial (e.g. the investigator considers that the patient will not follow the protocol scheduled) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatitis B Cirrhosis, Liver Chronic Liver Disease All the cirrhosis patients more than 18 years old presented to the hepatology clinic in Mercy Medical Center between 09/2020 and 07/2021 who do not have immunity against Hepatitis B (defined as anti-HBs titer < 10 mIU/ml) will be recruited Anyone who has had a serious allergic reaction to a prior dose of the hepatitis B vaccine, a component of the hepatitis B vaccine, or yeast should not receive the hepatitis B vaccine Those who had previous exposure to hepatitis B Post liver transplant patients Less than 18 years old | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-75.0, Esophageal Varices in Cirrhosis of the Liver The investigators plan to a total of 140 participants in this study, aged from 20 to 75-year-old Those participants with less than 20-year-old, having implanted electronic or magnetic devices, pregnant, or unable to swallow the capsule, will be excluded from the study | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hydrocephalus, Normal Pressure Diagnosis of idiopathic normal pressure hydrocephalus and planned treatment with shunt surgery Ongoing anticoagulation treatment Ongoing Clopidogrel treatment Mini mental state examination results of 15 or lower Contraindications to magnetic resonance imaging | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Esophageal Varices cirrhotic portal hypertension with medium or large sized or risky varices or variceal bleeding non-cirrhotic portal hypertension | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-99.0, Hypertension Primary care physician Practicing in primary care at Massachusetts General Hospital Caring for at least 10 patients: (1) aged 18-79, (2) for whom the average of their most recent 3 blood pressure measurements in the last 18 months is above goal, (3) whose most recent BP at an outpatient visit was above goal, and (4) who did not have their hypertension treatment regimens intensified (dose increase, new medication, or medication exchange) at or since that time. The BP goal will be <140/90 for patients aged 18-59 and <150/90 for patients aged 60-79, consistent with MGH population health metrics -None | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-90.0, Cirrhosis Cirrhosis, Liver Fibrosis, Liver Hepatocellular Carcinoma Hepatocellular Cancer Patients seen in secondary care with suspected or confirmed liver / pancreatic disease or hepatocellular carcinoma / pancreatic cancer Patients able to understand and retain the information provided, thereby being able to give informed consent for in this study Patients who lack capacity or unable to provide informed consent Any patient outside the established age range (18-90years) Patients unable to fast | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Anemia Chronic Liver Disease Age 18-75 years 2. Either gender 3. Patients with chronic liver disease with anemia (Hemoglobin in Non-pregnant women (18 years of age and above) <12g/dl and in men <13g/dl Those who do not consent to participate in the study 2. Renal dysfunction (S. Creatinine ≥ 2mg/dL) 3. Pregnancy/Lactation 4. Post liver transplant patients 5. HIV infection 6. Patients who are on psychoactive drugs, like sedatives or antidepressants 7. Patients with uncontrolled sepsis 8. Patients who are too sick to carry out the protocol 9. Patients with ongoing active bleeding 10. Patients with known primary hematological disorders | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Hepatic Impairment Healthy Participants - Participants with mild to moderate liver impairment must meet all of the following to enter the study The informed consent is signed before the trial, and the content, process and possible adverse reactions are fully understood; Be able to complete the study according to the requirements of the test scheme Both male and female, subjects aged 18 to 65 years (including both ends) on the date of signing informed consent The body weight of male subjects is ≥50 kg, while female subjects is ≥45 kg. Body mass index (BMI) is in the range of 18.5 kg/m2-30 kg/m2 Chronic stable primary liver disease is necessary for patients with liver impairment, then patients with Grade-A/mild liver impairment (Child-Pugh score: 5-6) and Grade-B/moderate liver impairment (Child-Pugh score: 7-6) are assessed according to Child-Pugh classification Provide documentary evidence of confirmed liver impairment Patients who have stable medication regimen for liver impairment, complications and other concomitant diseases within at least 28 days before taking the experimental drug, and the medication does not need to be adjusted (including drug type, dosage or frequency) during the clinical trials; or those who do not use the drug The function of vital organs meets the following Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L (1000 / mm3); Platelet ≥ 75.0 × 109 / L (75000 / mm3); Hemoglobin (Hgb) ≥ 9.0 g / dL (90g / L); ALT and AST ≤ 5ULN; Creatinine clearance rate (CLcr) ≥ 60 mL / min; The corrected QTc interval (QTcF) ≤ 450 msec (male), ≤ 470 msec (female) In addition to liver impairment and complications, the investigator judged good condition according to the history inquiry, vital signs, physical examination, routine laboratory examination, 12-lead ECG, EEG, etc., and there was no other clinically significant abnormality No family planning during the trial and within 6 months after the last administration of the trial drug, and voluntarily take effective contraceptive measures; Serum pregnancy test must be negative within 7 days before the experimental drug for women of childbearing age - Participants with mild to moderate liver impairment who meet any of the following will not be eligible for this study Subjects had any of the following conditions: drug-induced liver injury; history of liver transplantation; liver failure, or cirrhosis with grade 3/4 hepatic encephalopathy, esophageal and gastric varices bleeding and other complications considered inappropriate by researchers; severe / advanced peritoneal effusion or pleural effusion requiring puncture drainage and albumin supplement; patients with hepatorenal syndrome; patients with hepatorenal syndrome Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that affect bile excretion Patients with severe portal hypertension or previous portosystemic shunt, including transjugular intrahepatic portosystemic shunt In addition to primary liver diseases, those who had previously suffered from serious primary diseases of other important organs were not suitable for the trial according to the judgment of the researchers Any of the following conditions occurred within 6 months prior to the study: Myocardial infarction, severe / unstable angina, symptomatic congestive heart failure (NYHA class II-IV), supraventricular or ventricular arrhythmias History of malignant tumor in the past 5 years Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening History of drug use, or have a history of drug abuse in the past five years, or have a positive drug screening (except those with drug screening positive due to concomitant drug use) HIVAb positive, syphilisAb positive | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cirrhosis Portal Hypertension Gastroesophageal Varices age between 18 and 75 years clinically evident or biopsy-confirmed cirrhosis Varices diagnosed by endoscopy written informed consent red sign Active upper gastrointestinal bleeding | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-85.0, Telenursing years and older People with gastritis, pain and sleep problems Without hearing loss Without visual impairment Can speak Turkish Able to communicate by phone Literate Patients who voluntarily participated in the study Being under 18 Without gastritis With hearing disabilities With visual disabilities Can not understand and speak Turkish Unable to communicate by phone İlliterate Patients who did not agree to participate in the study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-999.0, Chronic Hepatitis b Age more than 20 years Presence of HBsAg positivity for more than 6 months that indicated chronic HBV infection HBV viral load more than 20000 IU/mL in HBeAg positive or more than 2000 IU/mL in HBeAg Negative CHB patients Presence of liver injury which was defined as histology activity index (HAI) >3 by Knodell necroinflammantion scoring system or liver fibrosis stage 2 or stage 3 by Metavir scoring system; Liver histology available for evaluation 6 months before starting screening is also acceptable. This is limited to subjects enrolling TAF treatment group ALT level between 1-2 folds of ULN for at least one occasion in recent 1 year before screening Treatment naïve Other etiology of chronic hepatitis; Those patients with spontaneous clearance of HCV defined as presence of anti-HCV antibody but undetectable of HCV RNA at least 3 months before enrollment and without history of anti-viral treatment could be included Severe comorbid disorders Uncontrolled diabetes mellitus (HBA1c > 8.5%) Current evidence or suspicious of malignancy Diagnosis of liver cirrhosis eGFR < or = 30 ml/min/1.73m2 Any one of following hematology or biochemical or clinical abnormalities: Albumin <3.5g/dL, Total Bilirubin >2.5mg/dL, prothrombin time prolongation >4 sec or INR >1.7, platelet count <100 x 103 uL, and history or presence of ascites or hepatic encephalopathy Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Cirrhosis Ascites Liver Diseases Frailty Sarcopenia Hepatic Encephalopathy Diagnosis of cirrhosis will be based upon: 1. liver biopsy, OR 2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR 3. 2 of the following 4 1. Ultrasound, Computed tomography (CT), or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) 2. Fibroscan liver stiffness score >13 kilopascals (kPa) 3. Laboratory testing: aspartate aminotransferase/platelet ratio index (APRI) >2.0 4. CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices Patients with history of > grade 2 HE within 180 days of enrollment based on review of clinical documentation verifying the event. If a description of HE symptoms is provided in clinical documentation, but it is unclear if it meets Grade 2 the principal investigator will assess the clinical documentation and provide an HE grade Non-English speaking Model for End-Stage Liver Disease (MELD) Score > 20 Pregnancy (self-reported) Unable or unwilling to provide consent History of liver transplant Current or planned admission to a nursing facility Serum creatinine > 2.0 milligrams per deciliter (mg/dL) (with the exception that we will patients with a serum creatinine > 2.0 mg/dL if they are receiving hemodialysis) Disorientation at the time of enrollment Barcelona-Clinic Liver Cancer (BCLC) Stage D Hepatocellular Carcinoma with Child-Turcotte-Pugh (CTP) Class C History of eating disorder | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Cancer, Lung Perfusion Computed Tomography Target Lesion Cancer Liver Metastatic Lung Cancer Metastatic Liver Cancer Patients suffering from primary malignant thoracic tumoral pathology or second line patients having had a therapy pause of at least 6 weeks; at least one tumoral lesion/component should have ≥15mm in diameter All patients willing to participate and to sign the informed consent All patients younger than 18-years-old Documented allergy for iodine Neutropenia (absolute White Blood Cell count ≤ 1.5 × 109/l) Thrombopenia (absolute platelet count ≤ 100 × 109/l) Renal insufficiency: serum creatinine ≥ 1.5× the upper limit of normal (ULN); 24-hours creatinine clearance ≤ 50ml/min) Serum bilirubine ≥ 1,5 x ULN, AST ≥ 2,5 x ULN, ALT ≥ 2,5x ULN Brain metastases | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Liver Cirrhosis Upper Gastrointestinal Bleeding Child score "A" Cirrhotic patients Hematemesis and / or melena Patient with unsuccessful endoscopic hemostasis Patients who already have signs of infections (elevation in the body temperature, elevation in white blood cells above 10,000 cell/mmᵌ) Patients with occult infection (defined as positive blood cultures obtained before antibiotic prophylaxis) Patients using antibiotics before endoscopy Patients refuse to participate in the study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Hepatic Encephalopathy The 1. cirrhosis due to HCV infection 2. age 18 to 75 years, 3. experiencing at least one episode of OHE, 4. MELD score ≤ 25 Patients with neurological or communication problems, 2. hepatocellular carcinoma 3. diabetes mellitus 4. active infection 5. serum creatinine > 2 mg/dl, Hg < 8 g/dL, serum Na < 125 mmol/L or serum K < 2.5 mmol/L . 6. Patients with previous intake of rifaximin as prophylaxis or any antibiotic within the last month | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 19.0-999.0, Cirrhosis, Liver Frailty Ascites Encephalopathy Infection liver cirrhosis (primarily on clinical grounds) decompensating event leading to hospital admission informed consent declined consent | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Acute Upper Gastrointestinal Bleeding Effect of Drug Age >= 18 years 2. Active upper GI bleeding ( defined as fresh or bright red hematemesis within 24hr. or presented of blood via NG aspiration ) 3. Underwent upper GI endoscopy within 12hr 4. Informed consent obtained Known allergy of metoclopramide 2. History of gastric or duodenal surgery 3. Known case esophageal, gastric or duodenal cancer 4. Diagnosed with advanced HIV infection (defined as CD4 cell count <200 cells/mm3 or WHO clinical stage 3 or 4) 5. Poor ambulatory status (defined as capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; applied from WHO/ECOG performance stage ≥3) 6. Pregnancy or lactating 7. NG lavage was done with solution > 50 ml | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Advanced Hepatocellular Carcinoma BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Refractory Hepatocellular Carcinoma Participants who are at least 18 years of age on the day of signing informed consent with confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) will be enrolled in this study Radiologic confirmation diagnosis is provided by the study site. Clinically confirmed diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) which requires Radiographically evident cirrhosis AND A liver mass that shows arterial phase hyperenhancement on triphasic computed tomography (CT) or magnetic resonance imaging (MRI), AND Is >= 20 mm with either non-peripheral portal washout or an enhancing capsule OR Is 10-19 mm with non-peripheral portal venous washout AND an enhancing capsule Have Barcelona Clinic Liver Cancer (BCLC) stage C disease, or BCLC stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach Have a Child-Pugh class A liver score within 14 days of first dose of study drug Have a predicted life expectancy of > 3 months A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies A WOCBP who has a positive urine pregnancy test within 72 hours prior to C1D1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to C1D1. Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to=< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment Has had esophageal or gastric variceal bleeding within the last 6 months Has clinically apparent ascites on physical examination Note: ascites detectable on imaging studies only are allowed Has had clinically diagnosed hepatic encephalopathy in the last 3 months. Subjects on rifaximin or lactulose to control their hepatic encephalopathy are not allowed Has received locoregional therapy to liver (transcatheter chemoembolization [TACE], transcatheter embolization [TAE], hepatic arterial infusion [HAI], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study drug. A 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-liver, non-central nervous system (CNS) disease Prior treatment with any Toll-like receptor (TLR) agonist Has liver lesions with macroscopic tumor infiltration into the main portal vein, hepatic vein, or inferior vena cava Has had major surgery to liver or other site within 4 weeks prior to the first dose of study drug | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Hydrocephalus Ventriculoperitoneal Shunt Age ≥ 18, regardless of gender. 2. Patients with hydrocephalus of high, normal and low pressure caused by various reasons need V-P shunt and meet the operation indications. 3. Before the start of the trial, a written informed consent signed by the subject himself or his legal representative must be obtained Patients who had participated in clinical trials of other drugs or medical devices within 6 months. 2. Patients with abnormal coagulation mechanisms or who had received treatment with thrombolytic agents, anticoagulants, or inhibitors of platelet coagulation within 2 weeks, and patients with hemophilia. 3. Patients with severe diseases of other systems, such as severe diseases of the hematological, respiratory, digestive, and urinary systems, were combined. 4. Patients with co-existing infectious diseases. 5. Pregnant, lactating female patient. 6. Physicians judged other situations in which they could not participate in the trial. 7. The subjects themselves or their legal surrogates refused to participate in the clinical trial | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Subarachnoid Hemorrhage, Aneurysmal Vasospasm, Cerebral Hydrocephalus >18 years of age harbour one or more saccular brain aneurysms with or without subarachnoid hemorrhage (SAH) multiple aneurysms absence of brain fusiform, traumatic or mycotic aneurysms SAH due to other causes (trauma, anticoagulation, antiplatelet medication, arteriovenous malformation, or tumor) any medical, neurological, or psychiatric condition that would impair patient's evaluation past medical history of bleeding disorders or liver diseases altering the coagulation anticoagulation platelet count <10x109/L prothrombin time >15 seconds | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Deglutition Disorders Outpatients refered to swallowing assessment at the Forcilles' hospital Medical indication to perform a videofluoroscopy Ultrasonographer available Age > 18 years old Membership of a social insurance sheme Patient provides consent Previous laryngectomy surgery Refusal to participate in the study Known pregnancy Person subject to judicial health protection Cognitive disorder incompatible with the understanding of instructions Patient under guardianship or curatorship | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Cholecystitis; Gallstone from 18 to 65 years old patients with acute or chronic cholecystitis, gallstone, gallbladder polyp and other benign gallbladder diseases BMI was 18-30 kg/m2 the American Society of Anesthesiologists (ASA) classification was I, II, or III women in pregnancy or lactation A history of epilepsy or mental illness Previous relevant operation history Patients with a severe cardiovascular and cerebrovascular disease with New York Heart Association (NYHA) classification III-IV and pulmonary insufficiency who cannot tolerate the operation Liver cirrhosis, kidney failure and other severe liver and kidney dysfunction (ALT and AST exceeded 3 times of the upper limit of normal value, Cr exceeded 1.5 times of the upper limit of normal value) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Cirrhosis Age ≥ 18 years old Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not Hospitalization for acute on chronic liver failure Ascites decompensation Or spontaneous infection of the ascites fluid (defined as PNN > 250/mm3 of ascites) Or digestive hemorrhage related to portal hypertension (digestive fibroscopy showing active bleeding or stigmas of recent bleeding from esophageal and/or gastric varices) Or hepatic encephalopathy (clinically defined +/ increase in ammonia and/or by electroencephalogram and classified in stages according to West-Haven) Or hepato-renal syndrome (HRS-AKI EASL 2018) Or bacterial infection (defined by a bacteremia identified by at least one blood culture and/or an infectious site authenticated on imaging) Treatment with oral or intravenous iron in the month prior to hospitalization Implementation of a TIPS in the month prior to admission Presence of hepatocellular carcinoma with an expected survival < 3 months or any other progressive cancer Adult person subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Cirrhosis Portal Hypertension Patient with cirrhosis and portal hypertension older than 18 old Patient who underwent a CT scan or MRI in the last 3 months The Mini-Mental State (MMS) test >25 Patient capable of receiving and understanding information relating to the study and of giving his written informed consent Patient affiliated to the French social security system Cirrhotic patient with overt HE or history of persistent or recurrent HE Hepatocellular carcinoma beyond Milan criteria Portal vein thrombosis Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt Presence of neurological or psychiatric disorder Patient with treatment by benzodiazepines or opioid substitution Pregnant or nursing women Patient in period of a previous study Patient under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatic Encephalopathy Willing to participate in the study and provide written informed consent Male and female adults aged > 18 years History of cirrhosis and at least 1 documented prior episode of overt hepatic encephalopathy within 24 weeks prior to Screening A PHES ≤ -4 during Screening MELD-Na score of <20 at Screening Support of a primary caregiver who is able and willing to give written informed consent Hospitalization or serious medical condiction History or presence of Child's Pugh class C, hepato-renal syndrome(s), refractory ascites or spontaneous bacterial peritonitis (SBP) History of a portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement Expectation of a liver transplant during the study Screening Alcohol Use Disorders Identification Test (AUDIT) score ≥8 | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cirrhosis Esophageal and Gastric Varices Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy Endoscopic treatment of uncontrollable bleeding Accompanied with other endoscopic treatments that need to be fasting With obvious hepatic encephalopathy and liver failure Did not sign the informed consent form and refused to participate | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-100.0, Upper Gastrointestinal Bleeding All patients presenting to ED with UGIB 2. Age more than 18 years of age Patients not consenting to study 2. Patients with known hematological disorders 3. Patients in which endoscopy or blood transfusion is done outside 4. Patients in which RDW value and laboratory parameters required for AIMS65 score are not available | 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): 12.0-999.0, Pneumonia, Pneumocystis Carinii HIV Infections Concurrent Medication: Allowed Antihypertensive agents. Concurrent Treatment: Allowed Blood products Ventilatory support. Prior Medication: Required At least 7 days trimethoprim / sulfamethoxazole or parenteral pentamidine Allowed Myelosuppressive or nephrotoxic agents including zidovudine, but must be discontinued during trial. No improvement in ventilatory status, defined as no change or a decrease in arterial or alveolar difference ((A-a) DO2) in the 72 hours prior to entry. (A-a) DO2 should be determined on room air, or receiving an FiO2 of 100 percent for 10 minutes via a tightly fitting non-rebreathing mask, or at an FiO2 of 100 percent for 10 minutes if the patient is being ventilated. Intolerance to TMP / SMX is defined as one or more of the following Platelets < 50000 platelets/mm3 or absolute neutrophil count (polys + bands) = or < 500 cells/mm3 on at least two occasions = or > 12 hours apart Blistering rash, mucosal involvement, generalized maculopapular eruption or intolerable pruritus Transaminase > 5 x ULN or = or > 300 IU if baseline abnormal Co-existing Condition: Patients with the following are excluded History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate Patients with less severe adverse reactions may be enrolled if, in the opinion of the investigator, they do not prohibit rechallenge with the drug. Concurrent Medication: Excluded Myelosuppressive or nephrotoxic agents Other investigational drugs including high-dose steroids (exceeding physiologic replacement doses). Patients with the following are excluded History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate Patients with less severe adverse reactions may be enrolled if, in the opinion of the investigator, they do not prohibit rechallenge with the drug | 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): 0.0-99.0, Benign Lymphoproliferative Disorder A. ALPS Natural History sample size and demographics: Study size: up to 1000 patients, patients, relatives and normal controls. Sex Distribution: Male and female Age range: All ages acceptable B. for Natural History Study: 1. To be considered as having ALPS, patients must elevated TCR alpha/beta+ CD4-8- peripheral blood DNT cells (equal to or greater than 1.5 percent of total lymphocytes or 2.5 percent of CD3+ lymphocytes) in the setting of normal or evalted lymphocyte counts. 2. A history of chronic (greater than 6 months) non-malignant, non-infectious lymphadenopathy and/or splenomegaly. 3. Willingness to allow blood, tissue and other samples to be stored. 4. Patients with RALD (RAS associated leukoproliferative disorders) who present with autoimmunity, lymphadenopathy and/or splenomegaly, with elevated or normal DNT s and somatic mutations in NRAS and KRAS C. for Screening potential patients: 1. A history of chronic (greater than 6 months) lymphadenopathy and/or splenomegaly. 2. Willingness to allow blood, tissue and other samples to be stored. D. Screening for ALPS Relatives: 1. Extended family members of an ALPS patient are eligible for genetic screening to determine if they carry the mutation found in their family. 2. Willingness to allow blood, tissue and other samples to be stored. E. of special populations: 1. Women who are pregnant or breast feeding are eligible to enroll as probands or relatives. However, certain obstetric issues may pose a safety risk for travel and evaluation here. for this group will be determined on a case by case basis by the PI. This protocol is not actively seeking women who are pregnant F. 1. Apheresis will be done only on healthy volunteers or patients with ALPS who have adequate peripheral venous access. Women of childbearing age must have a negative pregnancy test within 24 hours of the procedure and must not be breast-feeding Any condition that the Principal Investigator deems to be non-conducive to the research goals of the 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 Leukemia Diagnosis of chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) will be made according to the World Health Organization (WHO) diagnostic classification. A lymphocyte count in excess of 5000/mcl is typically found in the leukemic variant but is not a pre-requisite for a diagnosis of SLL. Low, Intermediate or High-Risk Category of CLL/SLL, using the Modified Three-Stage Rai Staging System as follows: Risk Category: Low Risk Rai Stage: 0 Clinical Features: Elevated blood and marrow lymphocyte numbers only (L). (lymphocytes greater than 5000/microl in blood, and lymphocytes greater than 30 percent in marrow). Risk Category: Intermediate Risk Rai Stage: I Clinical Features: L + enlarged lymph nodes (LN) Risk Category: Intermediate Risk Rai Stage: II Clinical Features: L + enlarged spleen or liver Risk Category: High Risk Rai Stage: III Clinical Features: L + anemia (Hemoglobin less than 11 gm/dl) Risk Category: High Risk Rai Stage: IV Clinical Features: L + thrombocytopenia (platelets less than 100,000/microl) Patients in the modified Rai high risk group and select patients in the intermediate risk group will undergo treatment with Rituximab Fludarabine. To meet treatment patients in the intermediate risk group should have evidence of active disease as demonstrated by at least one of the following 1. massive or progressive splenomegaly or lymphadenopathy; 2. presence of weight loss greater than 10% over the preceding 6 months; 3. constitutional symptoms of extreme fatigue, night sweats or recurrent fever of greater than 100 degrees F (documented fevers must be occurring without evidence of specific infection), and bone pain; 4. progressive lymphocytosis with an increase of greater than 50% over a 2 month period, or an anticipated doubling time of less than 6 months; 5. chronic infections either increased number or prolonged infections; 6. other high risk prognostic indicators such as excess elevation of beta-2-microglobulin, cluster differentiation 38 (CD38) expression and adverse cytogenetics may be used to better appraise the risk in each individual patient. Patients with a diagnosis of CLL/SLL who do not meet the for receiving Rituximab and Fludarabine (are not intermediate or high-risk CLL/SLL), can enroll on the protocol for the purpose of donating cellular products. Such patients will not receive rituximab and fludarabine chemotherapy. At a later date, if it is documented that the patient does meet the then the patient may receive Rituximab and Fludarabine (after discussion with the Principal Investigator). In a limited number of cases, patients with low-risk CLL/SLL may be initiated on Rituximab and Fludarabine treatment. For example, individuals who are candidates for bone marrow transplantation may be started on Rituximab Fludarabine as an induction regimen prior to transplantation. Additionally, some low-risk patients may be started on Rituximab and Fludarabine for psychological reasons (patient insistence on starting chemotherapy prior to disease progression). However, it must be stressed that low-risk CLL/SLL patients will be discouraged from initiating therapy except in these specific cases. Age greater than or equal to 18 years of age. Patients must have received no prior cytotoxic or monoclonal antibody therapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Required initial laboratory tests: Blood urea nitrogen (BUN) and Creatinine values must be less than or equal to 1.5 times the normal values; alternatively, patients with creatinine clearance of greater than 50 ml per minute will also be eligible. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values must be less than or equal to 2.0 times normal values; patients with laboratory values greater than these levels may be enrolled on the protocol (after a specific approval from the Principal Investigator) if the values are due to a known, pre-existing liver disease. Bilirubin must be less than or equal to 2.0 mg/dl unless due to Gilbert's disease. The patient must be competent to sign an informed consent, and sign the protocol consent form Patients must not be pregnant or breastfeeding. Patients with active autoimmune hemolytic anemia (AIHA)) grade III or higher (transfusion or steroids indicated) or immune thrombocytopenia (ITP) grade III or higher (platelets less than 50,000/microL) shall not be enrolled. Patients with a history of prior therapy to control either AIHA or ITP will be eligible, provided they do not require maintenance corticosteroids, and have not received monoclonal antibody therapy in the past 6 months. Patients developing AIHA or ITP on protocol may be managed as medically indicated on protocol but will generally not undergo fludarabine/rituximab treatment until resolution of hemolysis or thrombocytopenia to less than grade III. Any patient with a medical condition that requires chronic use of corticosteroids shall not be enrolled | 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, Hematologic Diseases Myelodysplastic Syndromes MDS of RA & RAEB sub-types. No current treatment and off other treatments for at least two weeks. ECOG performance status less than or equal to 2. No MDS of FAB sub-group' refractory anemia with ring sideroblasts' (RARS). No transforming to acute leukemia (FAB sub-group RAEB-Tie.; greater than 20% blasts in marrow aspirate). No hypoplastic marrow without one major or two minor as outlined in table 3 of the appendix. No one being treatment with growth factors or cyclosporine within four weeks prior to entry to protocol. No previous treatment with ATG. No ECOG performance status of greater than 2. No active uncontrolled infection. No women which current pregnancy, or unwilling to take oral contraceptives if of childbearing potential. No patients for whom bone marrow transplant is indicated as primary therapy. No one age less than 18 years. Must be able to give informed consent. No HIV positive patients. No active malignant disease (excluding basal cell carcinoma). No one with serum creatine greater than 2mg/dl. No patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic, or any disease of such severity that death within 7-10 days is likely | 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, HIV Infections Cytopenias Patients must have HIV seropositivity by Western blot Advanced ARC or AIDS as defined by CDC Cytopenia defined as total peripheral leukocyte count of < 3,000 cells/mm3 or platelet count of < 100,000 cells/mm3 or serum hemoglobin < 10 g/dl Anticipated life expectancy = or > 6 months Ambulatory Willing to sign informed consent Willing to forego use of any other investigational therapies except ddI. Prior Medication: Allowed > 2 weeks prior to study entry zidovudine Allowed > 4 weeks prior to study entry Co-existing Condition: Patients with the following conditions or symptoms are excluded Active opportunistic infection Symptoms of CNS disease referable to HIV infection Dementia or altered mental status that would prohibit giving and understanding informed consent. Systemic chemotherapy Investigational therapies other than ddI Medications with known myelosuppressive effects such as ganciclovir, trimethoprim/sulfamethoxazole or dapsone or AZT Other hematopoietic growth factor treatments as GM-CSF, G-CSF, or EPO. Prophylactic therapy for pneumocystis or oral thrush ddI Corticosteroids or topical corticosteroid creams. Patients may not have Life expectancy < 6 months | 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, Lymphatic Disease HIV Infections Co-existing Condition: Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded. Concurrent Medication: Excluded Systemic corticosteroids Cytotoxic immunosuppressive agents Radiotherapy. Critically ill patients or those with CDC-defined AIDS are excluded. Prior Medication: Excluded within 1 month of study entry Immunotherapy. Patients with persistent generalized lymphadenopathy (PGL) | 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, Leukemia Diagnosis of B-cell chronic lymphocytic leukemia (CLL) requiring therapy and meeting the following Previously untreated disease Peripheral blood morphology, excluding other leukemia and low-grade lymphoma in leukemic phase Cell markers: CD5+, CD23+, SmIg (weak), CD79b-, FMC7- Persistent lymphocytosis (greater than 10,000/mm^3) At least 40% bone marrow infiltration Stage 0 or I progressive disease indicated by at least one of the following Persistent rise in lymphocyte count with doubling time less than 12 months Downward trend in hemoglobin and/or platelet count At least 50% increase in size of liver and/or spleen and/or lymph nodes | 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, Liver Cancer Histologically proven hepatocellular carcinoma OR Elevation of alpha fetoprotein (AFP) (greater than 400 ng/mL) in the presence of a space occupying lesion in the liver with known chronic liver disease Lesion must be easily biopsied Unresectable disease Bidimensionally measurable disease by radiography OR Evaluable disease with elevated AFP Okuda stage I disease Tumor size less than 50% of liver No ascites Albumin greater than 3 g/dL Bilirubin less than 2 mg/dL OR Okuda stage II disease Bilirubin as in stage I If ascites present, albumin must be greater than 3 g/dL Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL Neutrophil count at least 1,500/mm3 Platelet count at least 80,000/mm3 Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Any cause of underlying liver disease including hepatitis B or C allowed Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poor cardiac function No myocardial infarction within the past 6 months No poorly controlled arrhythmia No congestive heart failure LVEF at least 45% by MUGA Other: No active hepatic encephalopathy No other active malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix HIV negative No immunodeficiency Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: At least 6 weeks since prior immunotherapy, including interferon Chemotherapy: No prior systemic or intra arterial doxorubicin At least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational therapy | 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 Histologic or cytologic diagnosis of indolent lymphoma as defined by International Working Formulation categories A-C or diagnosis of Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia Lymphoma must be stage III, IV, or recurrent (no primary CNS lymphoma or lymphomatous meningitis) Waldenstrom's macroglobulinemia must have at least one of the following IGM greater than 3,000 mg/dL Hemoglobin less than 10.0 g/dL Bone marrow involvement greater than 30% lymphocytes At least 2 cm lymphadenopathy Serum viscosity greater than 3.0 Chronic lymphocytic leukemia must be intermediate or high risk stages I-IV and have progressed on fludarabine therapy unless patient cannot tolerate fludarabine Intermediate risk group must have at least one indication of active disease | 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 Diagnosis of B-cell chronic lymphocytic leukemia manifested by all of the following: Minimum threshold peripheral lymphocyte count of at least 5,000/mm3 Small to medium sized peripheral blood lymphocytes with no greater than 55% prolymphocytes Bone marrow aspirate and biopsy containing at least 30% lymphoid cells Immunophenotypic and biopsy evaluation of peripheral blood lymphocytes demonstrating monoclonality of B lymphocytes B-cell markers with CD5 antigen (e.g., T-1, T-101) in the absence of other pan T-cell markers (e.g., CD3, CD2) Expression of CD19, CD20, and CD23 B cell surface markers B-cell expression of kappa or lambda light chains Active disease with at least one of the following One or more disease related symptoms: At least 10% weight loss within the past 6 months Fever greater than 100.5 F for at least 2 weeks without evidence of infection Night sweats without evidence of infection Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin less than 11.0 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm3) (i.e., any stage III or IV disease) Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy Massive (i.e., greater than 6 cm below the left costal margin) or progressive splenomegaly (i.e., a greater than 50% increase over two months) Massive (i.e., greater than 10 cm in longest diameter) or progressive lymphadenopathy (i.e., a greater than 50% increase over two months) Progressive lymphocytosis with an increase of greater than 50% over a 2 month period (unrelated to corticosteroids) or an anticipated doubling time of less than 6 months No marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any for active disease Previously treated with at least a fludarabine or cladribine based regimen and a prior alkylating agent with evidence of recurrent or progressive disease Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN (unless due to hemolysis or chronic lymphocytic leukemia) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial infarction within the past month Other: No uncontrolled infection HIV negative No other active malignancy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery | 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, Prostate Cancer Metastatic disease as evidenced by soft tissue and/or bony metastases Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA Tumor progression after hormonal therapy Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for treatment of prostate cancer. Castration levels of testosterone (< 50 ng/dL) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate A subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in PSA) but at the time of registration demonstrated tumor progression. A subject is eligible if he failed to respond to antiandrogen withdrawal Subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain ECOG Performance Status of 0 or 1 Life expectancy of at least 16 weeks Adequate hematologic, renal, and liver function Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites) Metastatic disease expected to be in need of radiation therapy within 4 months Concurrent therapy with experimental agents Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval. Please note that there are additional criteria. The study center will determine if you meet all of the criteria | 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 refractory, progressive, B-cell chronic lymphocytic leukemia Failed prior first line therapy of chlorambucil or fludarabine (or their equivalent) Progressive disease as defined by at least one of the following: Greater than 50% increase in the sum of the products of at least 2 lymph nodes on two consecutive determinations 2 weeks apart (at least one lymph node must be greater than 2 cm) Appearance of new palpable lymph nodes At least a 50% increase in size of previously palpable liver or spleen Appearance of palpable hepatomegaly or splenomegaly not previously present At least a 50% increase in the absolute lymphocyte count to at least 5,000/mm3 Transformation to an aggressive histology (e.g., Richter's or prolymphocytic leukemia) High risk OR Intermediate risk with active disease, as defined by the following: Greater than 10% weight loss Extreme fatigue Fevers greater than 100.5 Fahrenheit for greater than 2 weeks without infection Night sweats Splenomegaly greater than 6 cm Lymphadenopathy greater than 10 cm Lymphocytosis with a doubling time less than 6 months Age: 18 and over Performance status: ECOG or Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 2 weeks after study PRIOR Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: 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): 0.0-999.0, Splenomegaly Adults and children 18 years of age or greater will be studied. Enrolled in a primary stem cell transplant protocol that has been approved by the IRB. Potential subjects are people donating PBSC concentrates for HLA-compatible relatives as part of IRB approved protocols or donating PBSCs for laboratory investigations Donors who cannot remain in the Bethesda area for an additional 4 to 5 days following their donations will be excluded from the third ultrasound | 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, Lymphoma Diagnosis of intermediate grade B-cell CD20+ non-Hodgkin's lymphoma Failed to achieve initial complete response (CR) after at least 2 courses of standard chemotherapy OR Relapsed after CR and not eligible for autologous bone marrow transplant Measurable disease defined as one of the following: Bidimensionally measurable disease at least 2 cm in diameter by radiograph or CT scan Enlarged spleen extending at least 2 cm below the costal due to lymphomatous involvement Enlarged liver with focal lesions on CT scan or biopsy proven lesions Lymphomatous hepatic involvement must be biopsy proven for the liver to be sole area of measurable disease No evidence of CNS involvement 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: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3* Platelet count at least 100,000/mm3* *unless there is bone marrow involvement with lymphoma Hepatic: Bilirubin less than 3 mg/dL AST/ALT less than 2 times normal Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 45% by MUGA or echocardiogram Other: No prior malignancy within the past 10 years except squamous cell carcinoma or basal cell carcinoma of the skin or cervical cancer No evidence of infection HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR See Disease Characteristics No prior rituximab | 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 Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Diagnosis of one of the following Confirmed chronic lymphocytic leukemia (CLL), meeting the following Peripheral blood lymphocytosis greater than 5,000/mm^3 Co-expression of the CD5, CD19, CD20, and CD23 surface antigens Clonal kappa and lambda light chain expression Dim surface immunoglobulin expression Small lymphocytic lymphoma Relapsed or refractory disease Must have received at least 1 prior regimen containing fludarabine Meets one of the following | 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 prolymphocytic leukemia (PLL) or chronic lymphocytic leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior fludarabine, defined as: No response Disease progression while receiving therapy OR Relapse within 6 months of completion of last dose Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other severe concurrent disease No mental disorders No prior allergic reaction to rat or mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: 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): 18.0-999.0, Lymphoma Histologically confirmed relapsed or refractory intermediate, high-grade, or transformed non-Hodgkin's lymphoma Received 1-3 prior treatment regimens (cytoreductive chemotherapy followed by high-dose therapy with stem cell support considered 1 regimen) Measurable disease 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 terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3* Platelet count greater than 75,000/mm3* * Unless due to lymphomatous marrow involvement Hepatic: Bilirubin less than 1.5 mg/dL* SGOT/SGPT less than 2 times normal* * Unless due to lymphomatous involvement Renal: Creatinine less than 2.0 mg/dL* OR Creatinine clearance greater than 50 mL/min* * Unless due to lymphomatous involvement Cardiovascular: No active uncontrolled angina pectoris No New York Heart Association class II-IV heart disease No myocardial infarction within the past 6 months No history of recurrent deep venous thrombosis not associated with catheter placement Other: No other prior malignancy within the past 5 years except curatively treated cervical cancer or basal cell or squamous cell skin cancer No serious concurrent medical illness that would preclude study No active infection PRIOR Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No prior paclitaxel, docetaxel, or estramustine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: 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, Neck Pain This study will enroll patients with chronic neck pain (more than 3 months duration) with or without occipitally-based head pain and without signs of radiculopathy or myelopathy. They must have pain of at least moderate intensity (by their report and by a score of at least 3 out of 10 on a visual analogue pain scale) on at least four days out of a week and have had some limitations of activity on a weekly basis due to their neck pain. These subjects should not have had spinal manipulative treatment for at least two years and should not have had any adverse reactions to manipulative treatment or to benzodiazepines. They may not be regular users of benzodiazepine medications. They also should not be currently enrolled in an ongoing physical therapy program, though they may be taking analgesics, anti-inflammatories or other medications for their problem. They may continue with any ongoing exercise program. Subjects will also be excluded if they are pregnant, lactating or plan to be pregnant, if they have significant cardiac or pulmonary disease or if they plan on relocating during the course of the study. The subjects will also be evaluated by a trained and experienced manipulative practitioner (see below) for the presence of lesions which would be amenable to manipulation and by a medical physician for the absence of any contraindications to manipulative treatments | 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 Patients with Binet Stage A Chronic Lymphocytic Leukemia (CLL) WHO performance status of 2 or less A life expectancy of at least one year Greater than 18 years of age Availability of CLL cells which can be used for DNA extraction and processing A platelet count greater than 100 x 109/l Ability to provide full informed consent Previous chemotherapy or radiotherapy Presence of a monoclonal band on serum electrophoresis Presence of clinically significant levels of anti-DNA antibodies, anti-muscle antibodies or rheumatoid factors or who have active autoimmune disease Presence of antibodies to human immunodeficiency virus (HIV) and known carriers of hepatitis B or hepatitis C virus Presence of other serious medical condition e.g. congestive heart failure Presence of other malignancies Pregnancy, lactation, or not using contraceptive measures Concurrent use of other anti-cancer therapy Patients allergic to tetanus vaccine | 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, Stomatitis * Patients with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma * Eligible for fractionated total body irradiation (fTBI) plus high-dose chemotherapy followed by autologous PBPC support. * 18 years of age or older * Karnofsky performance status greater than or equal to 70% * Minimum of 1.5 Mio CD34+ cells/kg cryopreserved and to be transplanted * Informed consent for participation in the study * History of, or concurrent cancer other than NHL, Hodgkin's disease, AML, ALL, CML, CLL, multiple myeloma * Prior bone marrow or peripheral blood stem cell transplantation * Purged stem cell product * Currently active infection or oral mucositis * Congestive heart failure * Serum creatinine > 1.5x ULN * Direct bilirubin > 1.5x ULN * Transaminases > 3x ULN * Corrected DLCO < 50% of predicted * Subject is currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s). * Subject is pregnant (eg, positive human chorionic gonadotropin [HCG] test) or is breastfeeding. * Subject refuses to use adequate contraceptive precautions. * Known hypersensitivity to any of the products to be administered during dosing, including E coli-derived products. * Inability to give a truly 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): 2.0-100.0, Eosinophilic Myeloid Neoplasm Hypereosinophilic Syndrome All subjects must meet the established diagnostic for hypereosinophilic syndrome: eosinophilia greater than 1,500/mm(3) on two occasions, no secondary etiology for the eosinophilia despite careful clinical evaluation, and evidence of end organ damage (histologic evidence of tissue infiltration by eosinophils and/or objective evidence of clinical pathology in any organ system that is temporally associated with eosinophilia and not clearly attributable to another cause). All subjects must fit one of the following three categories: 1. refractory to or intolerant of steroids 2. presence of FIP1L1/PDGFRA by RT-PCR 3. presence of greater than or equal to 4 of the following laboratory suggestive of a myeloid disorder: i. dysplastic eosinophils on peripheral smear ii. serum B12 level greater than or equal to 1000 pg/ml iii. serum tryptase level greater than or equal to 12 iv. anemia and/or thrombocytopenia v. bone marrow cellularity greater than 80% with left shift in maturation vi. dysplastic (spindle-shaped) mast cells on bone marrow biopsy vii. evidence of fibrosis on bone marrow biopsy viii. dysplastic megakaryocytes on bone marrow biopsy 3. All subjects must be at least 2 years of age. 4. Negative serum beta-hCG within 24 hours prior to drug administration for women of childbearing potential to early pregnancy. 5. All subjects (men and women) must agree to practice abstinence or effective contraception during administration of imatinib mesylate or ruxolitinib and for 6 months after discontinuation of drug. Of note, failure of the standard chemotherapeutic agents (steroids, hydroxyurea, and interferon alpha) will not be a prerequisite for participation in this protocol for the following reasons. 1) There is no approved therapy for HES. 2) steroid therapy in the myeloid subset of HES patients is generally ineffective. 3) Although hydroxyurea and interferon alpha are initially effective in most cases, a majority of patients become refractory to or intolerant of these agents within a relatively short period of time (less than 1 year). 4) Data from other myeloid neoplasms and disorders, including CML, suggest that interferon, imatinib mesylate, and ruxolitinib, but not hydroxyurea, are associated with cytogenetic remission. 5) The reported incidence and severity of side effects from imatinib mesylate in patients with CML and ruxolitinib in myelofibrosis and polycythemia vera appear comparable to (or less than) those associated with interferon alpha. Subjects who meet but are already receiving imatinib, may be enrolled in the dose de-escalation portion of the study at the investigator s discretion. Although a private physician is not required for in the study, it is strongly recommended that all subjects have a physician outside the NIH for routine medical care and emergencies Pregnancy or nursing women 2. HIV positivity or other known immunodeficiency 3. D816V KIT-positive systemic mastocytosis 4. Absolute neutrophil count less than 1000/mm(3) or platelet count less than 10,000/mm(3) or less than 50,000/m(3) with clinical evidence of bleeding. 5. Elevated transaminases (greater than 5 times the upper limit of normal) or elevated bilirubin (greater than 3 times the upper limit of normal) 6. Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study 7. Evidence of B cell clonality by PCR or flow cytometry ( for ruxolitinib only) | 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, Lung Cancer Histologically confirmed non-small cell carcinoma of the lung May be confirmed at the initial bronchoscopy and mediastinoscopy Stage IB (T2, N0, M0) Stage IIA (T1, N1, M0) Stage IIB (T2-3, N0-1, M0) Stage IIIA (T1-3, N1-2, M0) stage IIIB (2 lesions in 1 lobe [T4]) No N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scaline) OR T4 primary tumor (malignant pleural effusion or mediastinal invasion) by clinical staging (seen on CT or PET scan and proven by mediastinoscopy) No metastatic disease (except N1 or N2 disease) or malignant pleural effusion* detected on preoperative evaluation No exudative effusions (even if cytologically negative) | 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 Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Waldenström Macroglobulinemia Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, including Waldenstrom's macroglobulinemia, as indicated by the following Massive or progressive splenomegaly and/or lymphadenopathy Anemia (hemoglobin less than 11 g/dL) or thrombocytopenia (platelet count less than 100,000/mm^3) Weight loss of more than 10% within the past 6 months Grade 2 or 3 fatigue Fevers greater than 100.5º C or night sweats for more than 2 weeks with no evidence of infection Progressive lymphocytosis with an increase of more than 50% over a 2-month period or anticipated doubling time of less than 6 months Received at least 1 prior therapy for CLL Performance status ECOG (Eastern Cooperative Oncology Group) 0-2 | 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 Diagnosis of CLL at any time in the past, as defined by all of the following: > 5 x 109 peripheral blood lymphocytes/L which are positive for CD5 and one or more B cell markers (CD19, CD20, CD23). < 55% of lymphocytes identified as prolymphocytes Intermediate or High Risk disease as defined by the Modified 3-stage system Patients with Intermediate Risk (Rai Stages I and II) must have active disease, as determined by one or more of the following 1. One or more of the following disease related symptoms i. Weight loss > 10% within the previous 6 months ii. Fevers of greater than 100.5°F for > 2 weeks iii. Night sweats without evidence of infection 2. Massive (i.e. > 6 cm below the left costal margin) or progressive splenomegaly 3. Massive lymph nodes or clusters (i.e. > 10 cm in longest diameter) or progressive lymphadenopathy 4. Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 12 months T cells (CD3+) comprising > 1.5% and < 10 % of peripheral white blood cells as assessed by flow cytometry CD4+/CD8+ of > 0.30, as assessed by flow cytometry Age of at least 18 years ECOG performance status of 0 to 2 Life expectancy 6 months Able to comprehend and provide signed informed consent Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study Evidence of Richter's Syndrome, T cell CLL, prolymphocytic leukemia, hairy-cell leukemia, splenic lymphoma with villous lymphocytes, large granular lymphocytosis, Sezary-cell leukemia, adult T-cell leukemia/lymphoma, or leukemic manifestations of non-Hodgkin's lymphoma Receipt of any chemotherapy, monoclonal antibody, investigational, or other systemic therapy for the treatment of CLL within 2 months prior to registration Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration Receipt of intravenous immunoglobulin (IVIG) within 1 month of registration Registration for, or plans to participate in, any other clinical trial concurrently for the duration of this trial History of malignancy other than CLL within five years of registration, except adequately treated basal or squamous cell skin cancer or in situ carcinoma of the cervix. Other exceptions must be approved by the Xcyte Therapies' Medical Monitor prior to registration Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration Liver disease or hepatitis as reflected by a serum bilirubin or ALT > 2.0 times the upper limit of normal laboratory range within 15 days of registration Compromised renal function as reflected by a serum creatinine > 2 times the upper limit of normal laboratory range within 15 days of registration History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g. idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if treatment with steroids has not been required in the two months prior to registration. Hypothyroidism without evidence of Grave's Disease or Hashimoto's thyroiditis is permitted | 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, Epstein-Barr Virus Infections All patients receiving a T cell depleted BMT from a mismatched family member or unrelated donor will be eligible for this protocol. In addition, patients receiving a matched sibling transplant or T replete transplant may be eligible if they are at high risk of developing EBV LPD because of their underlying disease (e.g Wiskott-Aldrich or Ataxia Telangiectasia) or have a past history of or other EBV associated malignancy O2 saturation > 90% on room air for BMT will be as detailed in the relevant protocol at time of administration CTLs Patients with GVHD of Grade II or greater Patients with severe renal disease (i.e., creatinine clearance less than half normal for age) Patients with severe hepatic disease (bilirubin greater than twice normal, or SGOT greater than 3 x normal) Patients with a severe intercurrent infection Patients with a life expectancy <6 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, Lymphoma Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the following Bone marrow lymphoplasmacytosis with: > 10% lymphoplasmacytic cells OR aggregates or sheets of one of the following: lymphocytes, plasma cells or lymphoplasmacytic cells on the bone marrow biopsy (measured within 4 weeks prior to registration) Measurable disease defined as a quantitative immunoglobulin M (IgM) monoclonal protein of > 1,000 mg/dL obtained within 4 weeks prior to registration Cluster of differentiation 20 (CD20) positive stain of bone marrow or lymph node samples obtained < 8 weeks prior to registration Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma, defined by 1 of the following Hemoglobin no greater than 11 g/dL Serum viscosity level relative to water of at least 4.0 centipoise Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Bilirubin no greater than 3.0 mg/dL Prior treatment for Waldenstrom's macroglobulinemia Prior anti-CD20 therapy Concurrent steroids exceeding 10 mg prednisone (or equivalent) per day Prior irradiation if less than 4 weeks had elapsed prior to registration and the date of last treatment Prior anthracyclines Prior malignancy except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer curatively treated with surgery alone and from which patient has been disease free for at least 5 years Active heart disease Pregnant or nursing Myocardial infarction within the past 3 months Congestive heart failure | 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, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hematopoietic/Lymphoid Cancer Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Splenic Marginal Zone Lymphoma Waldenström Macroglobulinemia Diagnosis of chronic lymphocytic leukemia (CLL) OR indolent non-Hodgkin's lymphoma (NHL) of any of the following subtypes Follicular lymphoma Grade I follicular small cleaved cell Grade II follicular mixed cell Grade II follicular large cell Diffuse small cleaved cell Small lymphocytic lymphoma Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia) AND Extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue [MALT] lymphoma) | 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 Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) Any stage, with or without B symptoms The following subtypes are eligible Diffuse large cell (B and T cell types) Anaplastic large cell Diffuse mixed cell Immunoblastic large cell Follicular large cell Transformed follicular NHL Diffuse aggressive not otherwise classified | 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): 15.0-999.0, Chronic Lymphocytic Leukemia Age >/=15 years. 2. Written informed consent. 3. Patients with chronic lymphoid malignancies that are either refractory to frontline therapy or have relapsed and that have a predicted probability of response of less than 20% with conventional therapy or allogeneic/autologous stem cell transplantation. 4. The following histologies are included: B-cell chronic lymphocytic leukemia (B-CLL or B-cell CLL), B-cell prolymphocytic leukemia (PLL), chronic lymphoid leukemia (CLL/PLL), hairy cell leukemia and hairy cell variant, mantle cell leukemia/lymphoma, marginal zone lymphoma/leukemia, splenic lymphoma with villous lymphocytes, CLL with evidence of transformation (e.g., Richter's transformation), large granular lymphocytic leukemia (LGL and NK-cell type). 5. Patients with above mentioned histologies whose malignant cell population have expressed both CD52 and CD20 in >/= 20% of cells as assessed by flow cytometry or immunohistochemistry. Expression of CD20 or CD52 < 20% is permitted if patients received rituximab or alemtuzumab, respectively, within 3 months prior to study start Patients who have previously received Rituximab and in combination are excluded. 2. ECOG performance status of </= 2. 3. Serum creatinine </= 2mg/dL and total bilirubin of £ 2 mg/dL unless due to direct infiltration of the liver or kidney with malignant cells. 4. Patients with a past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies are excluded <CDR = complementarity determining regions>. 5. Negative pregnancy test (serum or urine) if female and of childbearing potential only (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized). 6. No prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. No prior therapy with monoclonal antibodies for at least 4 weeks prior to study start. 7. Patients at high risk of hepatitis B virus (HBV) infection and active HBV infection are 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): 0.0-999.0, Myelodysplastic Syndromes MDS of RA, RARS & RAEB sub-types including those previously treated with chemotherapy or experimental agents such as retinoids, Vitamin D, and growth factors Anemia requiring transfusion support with at least one unit of packed red blood cells per month for greater than or equal to 2 months OR thrombocytopenia (platelet count less than 50000/ul) OR neutropenia (absolute neutrophil count less than 500/ul). Off all other treatments (except G-CSF, and transfusion support and related medications) for at least four weeks. G-CSF can be used before, during and after the protocol treatment for patients with documented neutropenia (less than 500/Ul) as long as they meet the for anemia and/or thrombocytopenia as stated above. ECOG performance status less than or equal to 2 High or intermediate predicted probability of response MDS of FAB sub-group chronic myelomonocytic leukemia (CMML) Transformation to acute leukemia (FAB sub-group RAEB-T, ie, greater than 20% blasts in marrow aspirate) Hypoplastic marrow without one major or two minor Treatment with growth factors (except for G-CSF) or cyclosporine within 4 weeks prior to entry to protocol Recent or current treatment (24 hours wash out period) with the herbal supplement Echinacea purpurea or Usnea barbata (Old Man's Beard) ECOG performance status of greater than 2 Active uncontrolled infection (chronic or current clinically significant infection, including hepatitis B or C virus infection) Current pregnancy, or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential Patients for whom bone marrow transplant is indicated as standard therapy (age less than fifty-five with a fully-matched sibling donor) Age less than 18 years Not able to understand the investigational nature of the study or give informed consent HIV positive patients Active malignant disease (excluding basal cell carcinoma) Serum creatinine greater than 2mg/dl Patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic, or any disease of such severity that death within 3 months is likely Low predicted probability of response | 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) meeting the following Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically Phenotypically characterized CLL defined by the following Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2) B cell expresses either kappa or lambda light chains Surface immunoglobulin with low cell surface density expression Requires chemotherapy, as indicated by any of the following Disease-related symptoms Weight loss of 10% or more within the past 6 months Bone marrow dysplasia related to prior therapy New York Heart Association class III or IV heart failure Prior lenalidomide Other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix Pregnant or nursing Concurrent oral or IV antibiotics for active infection | 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 Adult Diffuse Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Diagnosis of chronic lymphocytic leukemia (CLL) Relapsed, refractory, or transformed disease Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody Transformed CLL (Richters transformation), must meet both of the following Histologically confirmed lymphoma Measurable disease No CNS disease Performance status ECOG 0-2 | 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, Hippel-Lindau Disease Kidney Cancer Patients must satisfy all of the following to be eligible for study enrollment Clinical diagnosis of von Hippel Lindau disease Presence of one or more localized renal tumors for which surgical resection would be considered the standard approach Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of 17 AAG in patients less than 18 years of age, children are excluded from this study Life expectancy less than 3 months Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Patients must have normal organ and marrow function as defined below: white blood cells (WBC)count greater than or equal to 3,000/microliter, absolute neutrophil count greater than or equal to 1,500/microliter, platelet count greater than or equal to 100,000/microliter, Hgb greater than 10Gm/dl, serum creatinine less than or equal to 1.0 upper limit of normal (ULN) or measured 24 hour creatinine clearance greater than 60 ml/min,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.0 times the ULN, total bilirubin less than or equal to ULN(less than 3 times the normal limit (NL) in patients with Gilbert's disease) Negative hepatitis B surface antigen (HbsAg), human immunodeficiency virus type 1 (HIV-1) and nonreactive hepatitis C virus (HCV) No history of serious intercurrent illness At least four weeks from completion of any surgical or investigational therapy for von Hippel Lindau disease Prior or concomitant non-von Hippel Lindau associated malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin or any other malignancy from which the patient has remained disease free for more than five years Any renal tumor greater than 4cm in size Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (to grade 1 or less toxicity according to Common Terminology for Adverse Events version 3.0 (CTCAE 3.0) due to agents administered more than 4 weeks earlier Patients may not be receiving any other investigational agents Patients with known metastatic renal cell cancer Patients with a history of serious allergy to eggs Concomitant therapy with cytochrome P450 3A4 (CYP3A4) potent inhibitors Patients who are on CYP3A4 substrates and inducers qualify for enrollment for this study Pregnant women are excluded from this study because 17 AAG has the potential for teratogenic or abortifacient effects, and no data regarding its safety in pregnant women is available. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 17 AAG, breastfeeding should be discontinued if the mother is treated with 17 AAG Human immunodeficiency virus (HIV)-positive patients are excluded from the study because of unknown but potential pharmacokinetic interactions of anti-retroviral drugs with 17 AAG | 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, Cutaneous T-cell Lymphoma Sezary Syndrome Histologically confirmed diagnosis of Sezary syndrome Must be willing to discontinue concomitant medications for CTCL, including: *Oral steroids above 10 mg day washout, unless subject has Addison's Disease or adrenal insufficiency, *PUVA or UVB week washout, sunbathing, tanning beds, etc. and for the duration of the study, *Electron Beam for the duration of the study, *Chemotherapeutic agents day washout, *Bexarotene capsules or other oral biologics week washout, *Topical nitrogen mustard week washout, *Extracorporeal photopheresis week washout and for the duration of the study Must be at least 18 years of age and must be able to understand the written informed consent Subjects with autoimmune disease, HIV, and/or hepatitis Subjects who are pregnant 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, Chronic Lymphocytic Leukemia Age >= 18 years (CLL does not occur in the pediatric population) Signed informed consent World Health Organization (WHO) performance status of 0, 1, or 2 Patients with B-CLL who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. Patients previously treated with Campath-1H are eligible Serum creatinine <= 2mg/dL, total bilirubin <= 2mg/dL, and SGPT <= 3x upper limit of normal (ULN) unless due to direct infiltration of the liver or kidney with malignant cells Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal antibodies for at least 4 weeks prior to study start Pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception Patients with history of HIV positivity Active secondary malignancy Active uncontrolled infection or any major systemic or other illness 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 | 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 Age: 18 years and older Diagnosis of B-cell CLL by International Workshop on CLL (IWCLL) response Relapsed CD23+ B-cell CLL Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling or peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms Prestudy WHO Performance Status less than or equal to 2 Signed, written Institutional Review Board (IRB)-approved informed consent Men & women of reproductive potential must agree to follow accepted birth control methods during treatment for 3 months after completion of treatment Acceptable liver function: Bilirubin less than or equal to 2.0 mg/dL (26 µmol/L), AST (SGOT) &/or ALT (SGPT) less than or equal to 2 times upper limit of normal Acceptable hematologic status: Platelet count less than or equal to 50 x 10^9/L, ANC less than or equal to 1 x 109/L Acceptable renal function: Serum creatinine less than or equal to 1.5 times upper limit of normal Subjects who did not respond to prior FCR therapy (relapsed within 6 months of the last dose) Cancer 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 Subjects who have had a prior allogenic bone marrow transplant (BMT) or autologous BMT or peripheral stem-cell transplant (PBSCT) Known infection with HIV, hepatitis B, or hepatitis C Uncontrolled diabetes mellitus Uncontrolled hypertension Transformation to aggressive B-cell malignancy (e.g., larger B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia (PLL) Subjects with secondary malignancy requiring active treatment (except hormonal therapy) Subjects with medical conditions currently requiring long-term use (less than 1 month) of systemic corticosteroids | 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, Waldenstrom Macroglobulinemia Patients must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the following must be true: *Presence of cytopenias, defined as Hemoglobin < 11 gm%, or WBC < 2000/µl, or platelets < 100,000 µl; *Presence of extensive (>3 cm) or symptomatic lymphadenopathy or hepatosplenomegaly; *Presence of B symptoms (night sweats, fever, weight loss of >10% of the baseline); *Presence of severe neuropathy, not otherwise explained; *Progressive disease (increase in "M" by > 50% while observed, and decrease in hemoglobin by >2 gm%,and/or decrease in platelets by >50,000/µl, and/or increase in lymphadenopathy); *Serum albumin <2.5 gm%; *Persistently elevated β-2M >3.0 in the absence of renal impairment or active infection Hyperviscosity will be treated (in addition to plasmapheresis) only in the presence of any of the above All necessary baseline studies for determining must be obtained within 35 days prior to registration Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO must be > 50% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated Patients must have a creatinine < 3 mg/dl and a creatinine clearance > 30 ml/minute. Patients with a creatinine clearance of 30-50 ml will only receive a 50% cisplatin dose Patients must have adequate hepatic function defined as serum transaminases < 2 x ULN and direct bilirubin < 2.0 mg/dl Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with the exception of: *Patients that have received prior adriamycin > 450 mg/m2 and LVEF < 55%. Adriamycin will be omitted in these patients; *Patients with a creatinine clearance 30 ml/minute, who will receive 50% of the cisplatin dose No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines | 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, Burkitt Lymphoma Non-Hodgkins Lymphoma Atypical Burkitt Lymphoma Histologically documented Burkitt or atypical Burkitt according to World Health Organization (WHO) criteria Pathology must be reviewed at the Brigham and Women's Hospital (BWH) Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable disease The following may not be used as the sole site of measurable or evaluable disease: *ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease Age > 18 Laboratory data (within 2 weeks of study registration) ANC > 1500/ul platelet > 100,000/ul creatinine < 1.5 X normal creatinine clearance > 60 ml/min Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration for impending oncologic emergency are allowed Uncontrolled bacterial, fungal, or viral infection Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell carcinoma of the skin Serious comorbid disease. Clinically significant pulmonary symptomatology. In patients with a history of symptomatic pulmonary disease, pulmonary function tests (PFTs) should document an forced expiratory volume at 1 second (FeV1), forced vital capacity (FVC), and total lung capacity (TLC) of > 60% predicted and carbon monoxide diffusing capacity of the lung (DLCO) of > 50% predicted. No clinically significant cardiac symptomatology. The cardiac ejection fraction must be > 50% Pregnancy. All males and females with reproductive potential must consent to use an effective form of contraception while on study Major surgery within the previous 2 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): 18.0-75.0, AIDS Related Lymphoma HIV positive with a high grade Ann Arbor stage I to IV untreated non-Hodgkin's lymphoma of B-cell origin confirmed by biopsy. The following histologies are eligible: *Burkitt's lymphoma, *diffuse large B-cell with standard histological diagnosis, *Burkitt-like and high grade large cell immunoblastic lymphoma with immunophenotyping CD20 positive Good and intermediate prognostic group (no more than one of the following prognostic factors: *CD4 below 100/µl, *history of opportunistic infection, *Karnofsky index below 60 percent or ECOG over 2) Written inform consent to participate Active viral hepatitis 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): 18.0-90.0, Asthma COPD Sleep Apnea Syndromes Interstitial Lung Diseases Bronchiectasis Patients who had already attended a respiratory clinic on at least two occasions and in whom it was perceived that there was a need for continued follow up in a hospital clinic with review needed more often than once per year Patients with no need for physical examinations or investigations such as chest X-rays, blood tests or lung function tests at every attendance Patients who had access to a confidential telephone line Patients who had no mental, hearing or linguistic problems New patients or those who need frequent follow up Patients with mental or cognitive issues Patients requiring physical examination and testing | 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 Hodgkin's Disease Leukemia, Lymphocytic, Chronic Lymphoproliferative Disorders Any individual diagnosed with non-Hodgkin's lymphoma or Hodgkin's disease or chronic lymphocytic leukemia (CLL), who has a 1st degree relative (parent, sibling or child) with a lymphoproliferative disorder; or families in which the individual has a lymphoproliferative disorder, and an unusual clustering of frequent or premature solid tumors is also observed Family members of the individual, either affected or unaffected with lymphoma, who are contacted by the individual and agree to participate in the study Deceased family members may be included in the study. Public records such as death certificates may be used to confirm the history. Consent for medical records or tissue blocks will be obtained from the deceased family member's next of kin. The hierarchy of relatives defined as next of kin is spouse, offspring, parents and siblings. Archived tissue samples may be used for genetic research Age > 18 years Subjects without a family history of lymphoma | 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, Lung Cancer Colorectal Cancer To have lung or colorectal cancer and be treated with either oxaliplatin, carboplatin or cisplatin | 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, Multiple Myeloma Age ≥ 18 years Expected survival ≥ 6 months Pre-study performance status of 0, 1, or 2 according to the World Health Organization (WHO) Newly diagnosed or relapsed/refractory myeloma with histologic confirmation of multiple myeloma by the Department of Pathology at University of Michigan Cancer Center (UMCC) Not more than 3 lines of therapy for myeloma for patients with relapsed disease Documented Stage II or III multiple myeloma (Durie and Salmon, 1975) prior to initiation of first line therapy At least 4 cycles of first line (for newly diagnosed patients) or salvage (for relapsed/refractory patients) prior therapy and in a plateau of at least partial response (Blade et al, 1999) for at least 2 determinations 6 weeks apart At least 21 days from day 1 of the last cycle and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy Measurable M-proteins with greater than 1 g/dl serum monoclonal protein and/or greater than 0.5 g/24 hour urine light chain excretion Acceptable hematologic status within two weeks prior to patient registration, including Patients with impaired bone marrow reserve, as indicated by one or more of the following Platelet count < 100,000 cells/mm3 Hypocellular bone marrow Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) History of failed stem cell collection Myelodysplastic syndrome (MDS) or evidence of other than myeloma clonogenic abnormalities Prior radioimmunotherapy Prior anti-CD20 therapy Other than myeloma malignancy, except B-cell non-Hodgkin's lymphoma, basal and squamous cell carcinoma of the skin, and cervical and breast cancer in situ, unless patient is cancer free for > 3 years Central nervous system (CNS) involvement | 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, Lymphoma Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months Patients previously untreated Patients with at least one of the following symptoms requiring initiation of treatment Bulky disease at study entry according to the Groupe d'Etudes Lymphomes Folliculare (GELF) nodal or extranodal mass > 7cm in its greater diameter B symptoms Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 1 Elevated serum lactate dehydrogenase (LDH) or beta2-microglobulin Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) Symptomatic splenic enlargement Compressive syndrome Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma) Patients without a large tumor burden Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer Poor renal function: Serum creatinine > 150 μmol/L Known HIV infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Patients with contra-indication to interferon, adriamycin, or rituximab Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator Known sensitivity or allergy to murine products Adult patient under tutelage | 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, Lymphoma Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following subtypes Diffuse large B-cell lymphoma Follicular lymphoma (grades 1-3) Small lymphocytic lymphoma Transformed B-cell lymphoma Relapsed or refractory disease Disease failed to respond to or progressed after ≥ 2 prior treatment regimens (e.g., high-dose therapy [HDT] with stem cell transplantation [SCT]*) NOTE: *Patients who have received HDT with SCT are considered to have diminished bone marrow reserve Diminished bone marrow reserve AND/OR mild to moderate cytopenia, meeting 1 of the following Absolute neutrophil count ≥ 1,000/mm^3 but < 1,500/mm^3 (growth factor independent) WBC ≥ 2,000/mm^3 but < 4,000/mm^3 (growth factor independent) | 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 Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden Above the age of six, at the moment of Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg Informed consent signed by the patients or his legally accepted representative Under the age of six, at the moment of Tested negative for HAV and HBV antibodies | 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, Follicular Lymphoma study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass) study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass) contra-indication to anthracycline or interferon transformation into large cell lymphoma previous treatment localized stage without of large tumor mass patients HIV+ | 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, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections | 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 Diagnosis of B-cell CLL by standard clinical and immunophenotypic as specified by the NCI working group revised guidelines for diagnosis and treatment of CLL(32). 2. Binet stages A-C with evidence of active disease requiring treatment by the presence of one or more of the following at the time of study entry Disease related B symptoms (Fever > 38C [100.5F] for ≥ 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss > 10% within previous 6 mo.) Evidence of progressive marrow failure as manifested by A decrease in hemoglobin to < 10g/dL, or A decrease in platelet count to < 100 x 10(9)/L within the previous 6 months, or A decrease in absolute neutrophil count (ANC) to < 1.0 x 10(9)/L within 6 months Progressive lymphocytosis with an increase of > 50% over a 2 month period, or an anticipated doubling time of < 6 months Massive nodes or clusters(i.e., > 10 cm in longest diameter) or progressive lymphadenopathy Progressive splenomegaly to > 2cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinical visits ≥ 2 weeks apart. 3. No prior chemotherapy for CLL. 4. Age ≥ 18 at signing of informed consent. 5. World Health Organization (WHO) performance status ≤ 0-2 (Appendix B). 6. Platelet count > 50,000/μL, hemoglobin > 8.0 g/dl and absolute neutrophil count > 1000/μL. 7. Renal function ≤ 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine) 8. Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values). 9. Female patients of childbearing potential must have a negative pregnancy test (serum or urine Beta-human chorionic gonadotropin, Beta-HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 2 months following completion of treatment. 10. Signed EC/IRB-approved informed consent by patient prior to all study related procedures Active autoimmune manifestation of CLL such as ongoing hemolytic anemia or ITP 2. History of a second malignancy with the exception of cervical cancer,or resected basal cell carcinoma or other malignancies with no evidence of recurrence 5 or more years since diagnosis. 3. Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV). 4. Transformation to an aggressive B-cell malignancy such as Richter's transformation, prolymphocytic leukemia (PLL) or large B-cell lymphoma. 5. Clinical evidence of CNS involvement with CLL. 6. Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives. 7. Treatment with any investigational agent within 4 weeks of study entry. 8. The use of steroids, nonsteroidal anti-inflammatory drugs, regardless of indication (excluding prophylactic use of aspirin for prevention of acute myocardial infarction or stroke) 9. Pregnancy or currently breast feeding | 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, Leg Length Discrepancy Scoliosis Functional scoliosis patients who have lumbar scoliosis combined with significant structural LLD Adolescent idiopathic lumbar scoliosis patients without LLD Do not suit the | 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, B-CLL B-CLL that has failed fludarabine Performance status grade 3 | 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): 0.0-999.0, Lymphadenitis Kikuchi's disease | 0 |
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