Phase 2
Completed N=93
Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Source: ClinicalTrials.gov NCT00472056 ↗Enrolled (actual)
93
Serious AEs
43.0%
Results posted
Feb 2012
Primary outcomePrimary: Disease-free Survival (DFS) — 11.33; 9.635 months
Summary
Cohort 1: Patients who are less than or equal to 65 years of age.
1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
Cohort 2: Patients who are older than 65 years of age
1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
2. To determine the treatment related mortality (TRM)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival (DFS) |
11.33; 9.635 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination
- Age less than or equal to 80 years. There is no lower age limit for this study.
- Zubrod performance status of less than 2
- Negative pregnancy test in patients with child bearing potential
- Must be willing to sign informed consent
- Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.
Exclusion Criteria
- 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.
- Less than 3 weeks from last cytotoxic chemotherapy
- Serum bilirubin > 1.5 mg/dl
- Serum transaminases > 2X/ULN
- Serum creatinine > 1.6 mg/dl
- Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight
- Left ventricular ejection fraction of < 40%, unless cleared by cardiology
- Corrected DLCO of < 50%
- Patients who are on anticoagulants or antiplatelet agents.
Data sourced from ClinicalTrials.gov (NCT00472056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.