Rituximab Plus Lenalidomide (CC-5013) in Indolent Lymphoma
Research type
Research Study
Full title
A PHASE 3, DOUBLE-BLIND RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS PLACEBO IN SUBJECTS WITH RELAPSED/REFRACTORY INDOLENT LYMPHOMA
IRAS ID
132492
Contact name
John Gribben
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2013-001245-14
Research summary
Summary of Results
Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab. A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively. As a conclusion, Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.
REC name
London - Westminster Research Ethics Committee
REC reference
13/LO/1513
Date of REC Opinion
13 Dec 2013
REC opinion
Further Information Favourable Opinion