You are here
CALGB 50803 (Alliance): A phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
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.
Abstracts by Peter Martin:
- Meeting: 2016 ASCO Annual Meeting | Abstract No: e19007
Patient-reported outcomes data from a phase 2 study of idelalisib in patients with refractory indolent B-cell non-Hodgkin lymphoma (iNHL).Meeting: 2014 ASCO Annual Meeting | Abstract No: e19554