drugset / Trial / NCT01029730
Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
Phase 2
Completed
55 enrolled
SCRI Development Innovations, LLC
Cephalon · collabMillennium Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2014-10
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.6 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |