Lenalidomide plus rituximab is more active than lenalidomide alone in patients with recurrent follicular lymphoma with similar toxicity, a new study published online ahead of print in the Journal of Clinical Oncology has shown.

Previous research has demonstrated that lenalidomide and rituximab are active agents in follicular lymphoma, the most common type of indolent non-Hodgkin lymphoma, but combination regimens of the two have been evaluated in randomized trials.

For the phase 2 study, researchers enrolled 91 patients with recurrent follicular lymphoma and randomly assigned them 1:1 to receive rituximab 375 mg/m2 weekly for 4 weeks plus lenalidomide 15 mg/day on days 1-21, followed by 7 days off, in cycle 1, and then 20 mg/day on days 1-21 with 7 days off in cycles 2 through 12, or lenalidomide alone.

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Efficacy results showed that the overall response rate was 53% for lenalidomide alone and 76% for the combination (P=0.029). Of those, 20% and 39%, respectively, achieved complete responses. Median time to disease progression was 1.1 year for lenalidomide and 2 years for lenalidomide plus rituximab at the median follow-up of 2.5 years (P=0.0023).

In regard to safety, 36% of patients receiving lenalidomide completed 12 cycles compared with 63% of patients that received the combination.

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The rate of grade 3 to 4 adverse events was similar between treatment arms. The most common grade 3 to 4 adverse reactions included neutropenia, fatigue, and thrombosis.

The findings suggest that further studies are warranted to evaluate the addition of novel agents for the treatment of B-cell non-Hodgkin lymphoma.

Preliminary findings were presented at the 48th ASCO Annual Meeting in Chicago, IL, in 2012.


  1. Leonard JP, Jung SH, Johnson J, et al. Randomized trial of lenalidomide alone versus lenalidomide plus rituximab in patients with recurrent follicular lymphoma: CALGB 50401 (Alliance). J Clin Oncol. 2015. [epub ahead of print]. doi: 10.1200/JCO.2014.59.9258.