Prior to novel targeted agents for chronic lymphocytic leukemia (CLL), the best chemoimmunotherapy regimen in patients with non-del(11q) disease was unclear. The role of lenalidomide was also not defined. This phase 2 study randomized 342 untreated patients with non-del(11q) CLL requiring therapy to fludarabine plus rituximab (FR; n = 123), FR plus lenalidomide consolidation (FR+L; n = 109), or FR plus cyclophosphamide (FCR; n = 110) and compared 2-year progression-free survival (PFS) rates of each to the historical control rate with FC (60%). Patients with del(11q) in at least 20% of pretreatment cells continued with FCR (n = 27) or were reassigned to FCR+L (n = 31) and excluded from the primary analysis. Among non-del(11q) patients, 2-year PFS rates were 64% (90% confidence interval [CI], 57-71; FR), 72% (90% CI, 65-79; FR+L), and 74% (90% CI, 66-80; FCR); FR+L and FCR had rates significantly greater than historical control. Median PFS was significantly shorter with FR compared with FR+L (
Byrd, John C; Ruppert, Amy S; Heerema, Nyla A; Halvorson, Alese E; Hoke, Eva; Smith, Mitchell R; Godwin, John E; Couban, Stephen; Fehniger, Todd A; Thirman, Michael J; Tallman, Martin S; Appelbaum, Frederick R; Stone, Richard M; Robinson, Sue; Chang, Julie E; Mandrekar, Sumithra J; and Larson, Richard A, "Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy: results for CALGB 10404 (Alliance)." (2018). Journal Articles and Abstracts. 531.