Phase II Trial Shows Greater Activity With Lenalidomide/Rituximab vs Lenalidomide in Recurrent Follicular Lymphoma


Key Points

  • Response rate and time to progression were greater with lenalidomide/rituximab.
  • Rates of grade 3 or 4 adverse events were similar in the two groups.

In a phase II trial (Cancer and Leukemia Group B 50401/Alliance) reported in the Journal of Clinical Oncology, Leonard et al found that the addition of rituximab (Rituxan) to lenalidomide (Revlimid) produced a higher response rate and longer time to progression than lenalidomide alone in patients with recurrent follicular lymphoma who had previously received rituximab.

Study Details

In the trial, patients were randomly assigned to receive rituximab at 375 mg/m2 weekly for 4 weeks, lenalidomide at 15 mg/d on days 1 to 21 followed by 7 days of rest in cycle 1 and then 20 mg/d on days 1 to 21 followed by 7 days of rest in cycles 2 to 12, or lenalidomide plus rituximab. Patients had to have a time to progression of ≥ 6 months from their last rituximab dose.

The rituximab-alone arm was discontinued due to poor accrual. Among 46 patients randomly assigned to lenalidomide/rituximab and 45 randomly assigned to lenalidomide alone, median age was 63 years, and 58% had intermediate- or high-risk disease. Aspirin or heparin was recommended for patients at high risk of thrombosis.

Response Rate

Overall response rates were 76% (complete response in 39%) in the lenalidomide/rituximab group vs 53% (complete response in 20%) in the lenalidomide group (P = .029). At median follow-up of 2.5 years, median time to progression was 2.0 vs 1.1 years (P = .0023).

Adverse Events

Grade 3 or 4 adverse events occurred in 53% (grade 4 in 11%) vs 58% (grade 4 in 9%) of patients, including neutropenia in 20% vs 16%, fatigue in 13% vs 9%, and thrombosis in 4% vs 16% (P = .157). Twelve cycles of treatment were completed by 63% vs 36% of patients, due to a greater rate of progression or nonresponse in the lenalidomide group.

The investigators concluded: “[Lenalidomide/rituximab] is more active than lenalidomide alone in recurrent [follicular lymphoma] with similar toxicity, warranting further study in B-cell non-Hodgkin lymphoma as a platform for addition of novel agents.”

John P. Leonard, MD, of Weill Cornell Medical College and NewYork-Presbyterian Hospital, is the corresponding author for the Journal of Clinical Oncology article.

The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit

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