At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 54 enrolled
Drug / intervention
Bendamustine +1 moredrug
Likely dose
Bendamustine 90 mgfrom 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.
A Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)
In Brief
A Phase 3 clinical trial evaluating Bendamustine and Rituximab for Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma. Completed, enrolled 54 participants across 43 sites in 3 countries.
Detailed Summary
The primary objective of this study is to assess the effect of treatment with bendamustine on cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia method (QTcF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Mantle Cell Lymphoma
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionJun 2012
TodayJul 2026
First PostedFeb 23, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.4 years ago
Interventions
Bendamustinedrug
Bendamustine at 90 mg/m\^2 IV on Days 1 and 2 of a 28-day cycle.
Rituximabdrug
Rituximab at 375 mg/m\^2 IV on Day 1 of a 28-day cycle.