Conditions: Lymphoma
Keywords: Low grade lymphoma Previously untreated lymphoma Lymphoma first line bendamustine Treanda bortezomib Velcade rituximab Rituxan
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.

Interventions: intervention 1: Bendamustine intervention 2: Bortezomib intervention 3: Rituximab
Intervention descriptions: intervention 1: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles intervention 2: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles intervention 3: 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

Protocol document: