Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Completed · Phase 2
Conditions studied: Lymphoma
In brief
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)
Key facts
- Study ID
- NCT00472056
- Run by
- M.D. Anderson Cancer Center
- People needed
- 93
- Starts
- 2005-03-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2016-03-15
Who can join
Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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