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

Lymphoma and Plasma Cell Disorders
Session Type and Session Title: 
Poster Highlights Session, Lymphoma and Plasma Cell Disorders
Abstract Number: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 8521)
Peter Martin, Sin-Ho Jung, Jeffrey L. Johnson, Brandy Pitcher, Rebecca L. Elstrom, Nancy Bartlett, Kristie A. Blum, Kristy L. Richards, John Leonard, Bruce D. Cheson; Weill Cornell Medical College, New York, NY; Duke University School of Medicine, Durham, NC; Alliance Statistical Center, Duke University Medical Center, Durham, NC; Genentech, Inc., South San Francisco, CA; Siteman Cancer Center, Washington University School of Medicine in St. Louis, St. Louis, MO; The Ohio State University, Columbus, OH; The University of North Carolina at Chapel Hill, Chapel Hill, NC; Georgetown University Medical Center, Washington, DC

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Abstract Disclosures


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. Fifty pts completed 12 cycles of lenalidomide. Reasons for discontinuation included refusal/withdrawal (N=6), adverse events (N=4), progression (N=2), and extended treatment delay (N=1). Grade 3-4 hematologic toxicity included neutropenia (19%), lymphopenia (8%), and thrombocytopenia (2%). Febrile neutropenia occurred in 1 pt. Grade 3-4 non-hematologic toxicity occurring in at least 2 pts included rash (8%), infection (8%), pain (8%), fatigue (6%), tumor lysis (3%). The overall RR in evaluable subjects was 93% (53/57); the CR rate was 72%. There was no significant association between CR rate and FLIPI risk, histological grade, or bulky disease. The median time to CR was 10 weeks and 92% of PET-negative CRs occurred by 24 weeks. With a median follow-up of 2.3 years, the 2-year PFS is 89%. Conclusions: Lenalidomide plus rituximab was well tolerated and effective in pts with untreated FL. These data are similar to those reported with chemotherapy-based therapy and support evaluation of this regimen in randomized trials. Clinical trial information: NCT01145495.