Rituximab Maintenance After Autologous Transplantation

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research is to see if Rituxan (rituximab) therapy given after high dose chemotherapy and transplant of a patients own stem cells will prevent or delay the return of the lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

Criteria

Inclusion Criteria:

1. Patients with diffuse large B cell non-Hodgkin's lymphoma who are 5-6 months status post an autologous stem cell transplant and are in CR. Patients who are positive for t(14;18) by PCR or for BCL-2 by Southern blot are eligible provided there is no other disease present.

2. Absolute neutrophil count (ANC) > 1500/mm3 independent of growth factor support

3. No evidence of symptomatic cardiac or pulmonary disease

4. Platelet count > 75,000 mm3

5. Zubrod performance status of 2 or less.

6. Negative pregnancy test in patients of "child bearing potential"

Exclusion Criteria:

1. Uncontrolled active infection

2. Severe concomitant medical or psychiatric illness

3. Serum bilirubin > 2.0 mg/dl 4) Transaminases > 2xULN 5) Serum creatinine > 2.0 mg/dl