Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab (Rituxan®) and Lenalidomide (Revlimid®) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

• Status: Withdrawn
• Trial end date: 2014-08-01

Summary

CLL/SLL is an incurable disease with conventional chemotherapy, and there are limited treatment options available for patients who have become refractory to fludarabine- and alkylating-agent based regimens. Bendamustine is a recently FDA-approved agent with significant activity in CLL/SLL, including significant activity in the setting of fludarabine-refractory disease. However, durations of remission following bendamustine/rituximab combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab.

The incorporation of a maintenance therapy to overcome the shorter remission durations in this population is a reasonable and feasible option. In considering potential options for treatment of CLL/SLL as a maintenance strategy following induction chemotherapy, lenalidomide and rituximab are appealing options based on their convenient dosing schedules and recent evidence of acceptable toxicity and promising efficacy in combination therapy.

• Phase: Phase 2

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: Celgene Corporation; Genentech, Inc.
• Treatments: Bendamustine Hydrochloride; Lenalidomide; Rituximab; Thalidomide