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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT00225212
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Nov 30, 1997
Status verified
Sep 2014
Primary completion
Mar 31, 2003
Completion
Mar 31, 2003

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab after ASCT
    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 Measure

Event-free Survival (EFS) [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-

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By research site
Stanford University Medical Center· Stanford, CA

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