NCT01029730

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
DRUG	Bortezomib	Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
DRUG	Rituximab	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

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-10-01
• Completion: 2016-07-01
• First posted: 2009-12-10
• Last updated: 2016-08-19
• Results posted: 2015-12-28

Locations

20 sites across 1 country: United States