CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Bendamustine +2 moredrug
Likely dose
Bendamustine 90 mg/m2from 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.

Search/NCT01029730
NCT01029730Phase 2Completed
CompareCT.gov

Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

SCRI Development Innovations, LLC·interventional·Posted Dec 10, 2009·Updated Aug 19, 2016

In Brief

A Phase 2 clinical trial evaluating Bendamustine, Bortezomib, and 1 other intervention for Lymphoma. Completed, enrolled 55 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc., Cephalon

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2009
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2014
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 16.6 years ago

Interventions

Bendamustinedrug

Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles

Bortezomibdrug

Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles

Rituximabdrug

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