Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
The goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles. This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma|
- Complete Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]Percentage of responses showing complete disappearance of all signs of cancer in response to treatment.
- Overall Response Rate [ Time Frame: At 3 and 6 months during treatment, then 6 months post-treatment. ] [ Designated as safety issue: No ]Defined as the proportion of patients with confirmed complete or partial response (CR or PR) according to Revised Response Criteria for Malignant Lymphoma.
- Progression-free Survival [ Time Frame: at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years. ] [ Designated as safety issue: No ]Defined as the time from first treatment until objective tumor progression or death.
- Frequency of adverse events and their severity as a measure of safety. [ Time Frame: Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years. ] [ Designated as safety issue: Yes ]Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Other Name: TREANDA®Drug: Bortezomib
Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Other Name: VELCADE®Drug: Rituximab
Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
Other Name: Rituxan®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029730
Show 20 Study Locations
|Study Chair:||Ian W. Flinn, MD, PhD||SCRI Development Innovations, LLC|