Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01235793
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 18 years of age and ≤ 75 years of age
2. Patients must have Central Nervous System (CNS) involvement with a mature B-cell non-Hodgkin's Lymphoma, (WHO criteria)
3. Patients must meet one of the below criteria:
* Patients who have achieved a complete response (CR) or partial response (PR) after initial therapy for Central Nervous System (CNS) B-cell lymphoma, OR
* Patients with relapsed or progressed disease following therapy for CNS B-cell lymphoma who has achieved a subsequent CR or PR following salvage chemotherapy, OR
* Patients who are initially refractory to therapy for CNS B-cell lymphoma but who have achieved a CR or PR following a salvage chemotherapy regimen, OR
* Patients who have developed CNS relapse from systemic B-cell Non-Hodgkin's lymphoma, and have evidence of chemotherapy sensitive lymphoma.
4. Patients fit for autologous stem cell transplantation
5. Patients able to understand and willing to sign a written informed consent document
Exclusion Criteria:
1. Patients whose life expectancy is severely limited by diseases other than malignancy
2. Karnofsky Performance Score \<60
3. Patients who are pregnant or breastfeeding
4. Patients who are HIV seropositive
5. Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
6. Patients with symptomatic coronary artery disease, uncontrolled congestive heart failure. Left Ventricular Ejection Fraction is not required to be measured, however if it is measured, patient is excluded if ejection fraction is \<30%
7. Patients requiring supplementary continuous oxygen. DLCO is not required to be measured, however if it is measured, patient is excluded if DLCO \<35%.
8. Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function and histology, and for the degree of portal hypertension. Patients with any of the following liver function abnormalities will be excluded
1. Fulminant liver failure
2. Cirrhosis with evidence of portal hypertension or bridging fibrosis
3. Alcoholic hepatitis
4. Esophageal varices
5. A history of bleeding esophageal varices
6. Hepatic encephalopathy
7. Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
8. Ascites related to portal hypertension
9. Chronic viral hepatitis with total serum bilirubin \>3 mg/dL
10. Symptomatic biliary disease
9. Patients with non-B-cell lymphomas or brain tumors that are not lymphomas are Excluded from the study. Non-B-cell lymphomas include: any T-cell lymphoma, natural killer (NK)-cell lymphomas, and Hodgkin lymphomas
10. Patients for whom an insufficient number of stem cells (\<2 X 106/kg) have been collected
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01235793
Study Brief:
Protocol Section:
NCT01235793