Leonard JP, et al. - Researchers assessed the efficacy of rituximab plus lenalidomide (an immunomodulatory agent), vs placebo plus rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma in this phase 3, multicenter, randomized trial. Findings revealed improved the effectiveness of rituximab when given in combination with lenalidomide (rituximab plus lenalidomide) in patients with recurrent indolent lymphoma. This combination displayed a satisfactory safety profile.

Methods

• The participants were patients with relapsed and/or refractory follicular or marginal zone lymphoma.
• The treatment regimen consisted of administration of lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5.
• Progression-free survival per independent radiology review was considered as the primary end point.

Results

• In a random manner, lenalidomide plus rituximab was received by 178 patients and placebo plus rituximab by 180.
• Lenalidomide plus rituximab was associated with a more common occurrence of infections (63% vs 49%), neutropenia (58% vs 23%), and cutaneous reactions (32% vs 12%).
• Lenalidomide plus rituximab was also related to higher grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%); no other grade 3 or 4 adverse event had a between-group difference of 5% or more.
• A significantly improved progression-free survival was reported for lenalidomide plus rituximab vs 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) vs 14.1 months (95% CI, 11.4 to 16.7 months), respectively.