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

Study Overview
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Brief Summary
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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.

Detailed Description
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The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant. After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.

Official Title
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Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma

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

Intervention / Treatment
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* Drug: Rituximab 375 mg/m2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab after ASCT<br>Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT. | Drug: Rituximab 375 mg/m2<br> <br> * Other names: chimeric anti-CD20;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free Survival (EFS) | Events for EFS were defined as the earlier of post-ASCT relapse or death. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-Hodgkin's lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, transformed lymphoma, other subtypes of B cell lymphoma, recurrent lymphoma