Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00265928|
Recruitment Status : Terminated (Withdrawn for poor accrual)
First Posted : December 15, 2005
Last Update Posted : January 28, 2008
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, including Waldenstrom's macroglobulinemia.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: bortezomib Drug: rituximab Procedure: antibody therapy Procedure: biological therapy Procedure: enzyme inhibitor therapy Procedure: monoclonal antibody therapy||Phase 2|
- Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory, B-cell non-Hodgkin's lymphoma.
- Determine the overall response rate (partial response, complete response unconfirmed, and complete response) in these patients.
- Estimate the duration of response in patients treated with this regimen.
- Estimate the time to disease progression in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV over 3-5 seconds once weekly in weeks 1-4 and rituximab IV over 5-6 hours once weekly in weeks 1-5*. Treatment repeats every 5 weeks for 2 courses. Patients achieving stable disease or better receive an additional 4 courses of bortezomib alone.
NOTE: *Patients receive rituximab in weeks 1-3 only during course 2 of treatment.
After completion of study treatment, patients are followed periodically for at least 18 months.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Masking:||None (Open Label)|
|Official Title:||VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma|
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): NCT00265928
|United States, Virginia|
|University of Virginia Cancer Center at UV Health System|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||John Densmore, MD||University of Virginia|