Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma (BVR)
The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma|
- Number of Participants With Progression Free Survival at 2 Years [ Time Frame: Two years ] [ Designated as safety issue: No ]To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.
- Toxicity of Drug Combination in the Subjects [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
- Overall Response Rate (ORR) [ Time Frame: Two years ] [ Designated as safety issue: No ]Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.
|Study Start Date:||October 2007|
|Study Completion Date:||October 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Lymphoma Subjects receiving protocol therapy
Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.
1.3 mg/m^2 on days 1, 4, 8, 11
Other Name: VelcadeDrug: bendamustine
90 mg/m^2 days 1 and 4
Other Name: TreandaDrug: rituximab
375 mg/m^2 day 1
Other Name: Rituxan
|United States, Nebraska|
|Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, New York|
|Cornell Wiell Medical College|
|New York, New York, United States, 10021|
|University of Rochester Medical Center (James P. Wilmot Cancer Center)|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Jonathan Friedberg, md||University of Rochester|