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

Phase 2

Completed

• Conditions: Diffuse Large Cell Lymphoma; Lymphoma; Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma; Transformed Lymphoma; Other Subtypes of B-cell Lymphoma
• Interventions: Drug: Rituximab 375 mg/m2

• Registration Number: NCT00225212
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 1997-11
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2005-09-21
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-23
• Results First Submitted: 2014-08-26
• Results First Submitted QC: 2014-08-26
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Results First Posted: 2014-09-05
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab after ASCT	Rituximab 375 mg/m2	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.

Primary Outcome Measures

Name	Time	Method
Event-free Survival (EFS)	24 months	"Events" for EFS were defined as the earlier of post-ASCT relapse or death.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	24 months

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States