Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
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ClinicalTrials.gov Identifier: NCT01029730 |
Recruitment Status
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Completed
First Posted
: December 10, 2009
Results First Posted
: December 28, 2015
Last Update Posted
: August 19, 2016
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Sponsor:
SCRI Development Innovations, LLC
Collaborators:
Millennium Pharmaceuticals, Inc.
Cephalon
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
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Tracking Information | ||||
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First Submitted Date ICMJE | December 8, 2009 | |||
First Posted Date ICMJE | December 10, 2009 | |||
Results First Submitted Date | November 19, 2015 | |||
Results First Posted Date | December 28, 2015 | |||
Last Update Posted Date | August 19, 2016 | |||
Study Start Date ICMJE | March 2010 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Complete Response Rate [ Time Frame: 18 months ] Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.
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Original Primary Outcome Measures ICMJE |
To determine the complete response rate in patients with previously untreated low grade lymphoma following treatment with bendamustine/bortezomib/rituximab. [ Time Frame: 18 months ] | |||
Change History | Complete list of historical versions of study NCT01029730 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma | |||
Official Title ICMJE | Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma | |||
Intervention ICMJE |
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Study Arms | Experimental: Bendamustine/Bortezomib/Rituximab
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.
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
55 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | July 2016 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01029730 | |||
Other Study ID Numbers ICMJE | SCRI LYM 66 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | SCRI Development Innovations, LLC | |||
Study Sponsor ICMJE | SCRI Development Innovations, LLC | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | SCRI Development Innovations, LLC | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |