Status:
COMPLETED
Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Lymphoma
Eligibility:
All Genders
Up to 80 years
Phase:
PHASE2
Brief 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...
Detailed Description
Carmustine, cytarabine, etoposide, melphalan, and rituximab are all standard chemotherapy drugs. If you are found to be eligible to take part in this study, you will be randomly assigned (as in the t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00472056
Start Date
March 1 2005
End Date
June 1 2012
Last Update
March 15 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030