CALGB 50803 (Alliance): A phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma.

8521 Background: The CALGB 50401 randomized phase II trial demonstrated the safety and efficacy of lenalidomide plus rituximab in (pts) with previously treated follicular lymphoma (FL). CALGB 50803 was a multicenter phase II trial of lenalidomide plus rituximab in pts with previously untreated FL. Methods: Pts with grade 1-3a FL, stage 3-4 or bulky stage 2 (> 7 cm), FLIPI 0-2, and no prior systemic therapy were eligible to receive rituximab 375 mg/m2 weekly x 4 during cycle 1 and day 1 of cycles 4, 6, 8, and 10, plus lenalidomide 20 mg on days 1-21 for a total of twelve 28-day cycles. Restaging was performed on weeks 10, 24, and 52, then q4 months for 2 years, and q6 months until progression for up to 10 years. The primary objective was to evaluate complete response (CR) rate based on 2007 IWG criteria. Results: From October 2010 to September 2011, 65 subjects were enrolled. Median age was 53 years; 34 were female; 14 had bulky disease; 20 were FLIPI 0-1, 41 FLIPI 2, 2 FLIPI 3; and 2 had insufficient data...