At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 447 enrolled
Drug / intervention
bendamustine +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Apr 7, 2009·Updated Feb 5, 2018
In Brief
A Phase 3 clinical trial evaluating bendamustine, rituximab, and 4 other interventions for Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma. Completed, enrolled 447 participants across 128 sites in 7 countries.
Detailed Summary
The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Mantle Cell Lymphoma
CountriesAustralia, Brazil, Canada, Mexico, New Zealand, Peru, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartApr 2009
Primary CompletionMar 2012
TodayJul 2026
First PostedApr 7, 2009
Enrollment StartApr 30, 2009
Primary CompletionMar 31, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.2 years ago
Interventions
bendamustinedrug
rituximabdrug
vincristinedrug
prednisonedrug
cyclophosphamidedrug
doxorubicindrug