• John P Leonard, Sin-Ho Jung, Jeffrey Johnson, Brandelyn N Pitcher, Nancy L Bartlett, Kristie A Blum, Myron Czuczman, Jeffrey K Giguere, and Bruce D Cheson.
• John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program, Greenville, SC; and Bruce D. Cheson, Georgetown University Hospital, Washington, DC. jpleonar@med.cornell.edu.
• J. Clin. Oncol. 2015 Nov 1; 33 (31): 3635-40.

PurposeLenalidomide and rituximab (LR) are active agents in follicular lymphoma (FL). Combination regimens have not been previously assessed in randomized studies.Patients And MethodsThe Cancer and Leukemia Group B (Alliance) 50401 trial is a randomized phase II trial studying rituximab (375 mg/m(2) weekly for 4 weeks), lenalidomide (15 mg per day on days 1 to 21, followed by 7 days of rest, in cycle 1 and then 20 mg per day on days 1 to 21, followed by 7 days of rest, in cycles 2 to 12), or LR. The rituximab-alone arm was discontinued as a result of poor accrual. Eligibility included recurrent FL and prior rituximab with time to progression of ≥ 6 months from last dose. Aspirin or heparin was recommended for patients at high thrombosis risk.ResultsNinety-one patients (lenalidomide, n = 45; LR, n = 46) received treatment; median age was 63 years (range, 34 to 89 years), and 58% were intermediate or high risk according to the Follicular Lymphoma International Prognostic Index. In the lenalidomide and LR arms, grade 3 to 4 adverse events occurred in 58% and 53% of patients, with 9% and 11% of patients experiencing grade 4 toxicity, respectively; grade 3 to 4 adverse events included neutropenia (16% v 20%, respectively), fatigue (9% v 13%, respectively), and thrombosis (16% [n = 7] v 4% [n = 2], respectively; P = .157). Thirty-six percent of lenalidomide patients and 63% of LR patients completed 12 cycles. Lenalidomide alone was associated with more treatment failures, with 22% of patients discontinuing treatment as a result of adverse events. Dose-intensity exceeded 80% in both arms. Overall response rate was 53% (20% complete response) and 76% (39% complete response) for lenalidomide alone and LR, respectively (P = .029). At the median follow-up of 2.5 years, median time to progression was 1.1 year for lenalidomide alone and 2 years for LR (P = .0023).ConclusionLR is more active than lenalidomide alone in recurrent FL with similar toxicity, warranting further study in B-cell non-Hodgkin lymphoma as a platform for addition of novel agents.© 2015 by American Society of Clinical Oncology.

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