Overview

Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Carmustine
Cytarabine
Etoposide
Etoposide phosphate
Melphalan
Rituximab
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.