Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.

This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.

Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• B-cell, CD20+ NHL

• Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

• Creatinine < 2 mg/dL

• Bilirubin < 2.0 mg/dL

• Liver function tests (LFTs) < 5 x upper limit of normal (ULN)

Exclusion Criteria:

• Graft source from bone marrow

• Non-responders [progressive disease (PD) or stable disease (SD)] to prior anti-CD20 therapy

• PD after ASCT

• Post-ASCT radiotherapy

• Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab

• Evidence of active pneumonitis

• Evidence of active infection

• Concurrent prednisone or other systemic steroid medication

• Nitrosourea therapy within 6 weeks of the first treatment with rituximab

• Presence of anti-murine antibody (HAMA) reactivity