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

Completed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma, Transformed Lymphoma, Other Subtypes of B-cell Lymphoma, Lymphoma

In brief

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.

Key facts

Study ID

NCT00225212

Run by

Stanford University

People needed

35

Starts

1997-11-01

Expected to finish

2003-03-01

Last updated by the study team

2014-09-15

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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