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)

Sponsor
University of Wisconsin, Madison
Study ID
NCT01754870
Phase
PHASE2
Status
Withdrawn

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2013
Status verified
Jul 2015
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustine + Rituximab-->Rituximab and Lenalidomide
    Induction chemoimmunotherapy: * Bendamustine 70 mg/m2 IV days 1 \& 2 every 28 days X 6 cycles * Rituximab 500 mg/m2 IV day 1 every 28 days X 6 cycles (375 mg/m2 IV cycle 1 only, day 1 or 2) Maintenance phase: * Rituximab 375 mg/m2 IV on day 1 of every odd-numbered 28 day cycle for a maximum of 12 doses during the maintenance phase. * Lenalidomide 5 mg orally daily on days 1-28 of each 28-day cycle for 24 cycles (maintenance cycles 1-24); dose escalation to 10 mg orally daily will be allowed at the start of cycle 2 or at the start of any subsequent cycle in subjects with acceptable toxicities needed to escalate the dose of lenalidomide to 10 mg/day.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 30 months ]

Related Studies