Clinical Trials Directory

Trials / Completed

CompletedNCT00225212

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
16 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGRituximab 375 mg/m2

Timeline

Start date
1997-11-01
Primary completion
2003-03-01
Completion
2003-03-01
First posted
2005-09-23
Last updated
2014-09-15
Results posted
2014-09-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00225212. Inclusion in this directory is not an endorsement.