Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
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|ClinicalTrials.gov Identifier: NCT01029730|
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : December 28, 2015
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Bendamustine Drug: Bortezomib Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||July 2016|
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®
Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Other Name: VELCADE®
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®
- Complete Response Rate [ Time Frame: 18 months ]Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.
- Overall Response Rate [ Time Frame: At 3 and 6 months during treatment, then 6 months post-treatment. ]The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Median 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. ]The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Participants With Adverse Events 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. ]Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in >1 patient
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): NCT01029730
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|Study Chair:||Ian W. Flinn, MD, PhD||SCRI Development Innovations, LLC|