A randomised phase II study was undertaken in which patients with recurrent follicular lymphoma received either lenalidomide alone (n = 45) or lenalidomide plus rituximab (LR) (n = 46). Overall response rate was 53% for lenalidomide alone compared with 76% for LR (p = 0.029). The median time to progression was 1.1 years at the median follow up 2.5 years. Grade 3 to 4 adverse events (AEs) occurred in 58% of patients in the lenalidomide arm and 53% of patients in the LR arm. Grade 3 to 4 AEs included neutropenia, fatigue and thrombosis. Lenalidomide alone had more treatment failures with 22% of patients stopping treatment because of AEs.
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