Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00225212|
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : September 5, 2014
Last Update Posted : September 15, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma Transformed Lymphoma Other Subtypes of B-cell Lymphoma Lymphoma||Drug: Rituximab 375 mg/m2||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||November 1997|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||March 2003|
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.
Drug: Rituximab 375 mg/m2
- Event-free Survival (EFS) [ Time Frame: 24 months ]"Events" for EFS were defined as the earlier of post-ASCT relapse or death.
- Overall Survival (OS) [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225212
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sandra J Horning, MD||Stanford University|