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:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00472056
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority
2. Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination
3. Age less than or equal to 80 years. There is no lower age limit for this study.
4. Zubrod performance status of less than 2
5. Negative pregnancy test in patients with child bearing potential
6. Must be willing to sign informed consent
7. Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.
Exclusion Criteria:
1. Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study.
2. Less than 3 weeks from last cytotoxic chemotherapy
3. Serum bilirubin \> 1.5 mg/dl
4. Serum transaminases \> 2X/ULN
5. Serum creatinine \> 1.6 mg/dl
6. Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight
7. Left ventricular ejection fraction of \< 40%, unless cleared by cardiology
8. Corrected DLCO of \< 50%
9. Patients who are on anticoagulants or antiplatelet agents.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
80 Years
Study:
NCT00472056
Study Brief:
Protocol Section:
NCT00472056