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ZYDELIG is indicated for relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities
Idelalisib (ZYDELIG) + rituximab is a PREFERRED treatment option in the NCCN Guidelines® for appropriate patients with relapsed/refractory CLL2*
Key eligibility criteria
Therapy maintained until disease progression or unacceptable toxicity
Secondary endpoints included:
Studied in a clinically challenging patient population3-6
Patient baseline characteristics3-5
*Please see the complete version of the NCCN Guidelines® for CLL/SLL (V.3.2018) available on NCCN.org for specific recommendations.
†Patients received 8 doses of rituximab: First dose at 375 mg/m2, subsequent doses at 500 mg/m2 for weeks 2, 4, 6, 8, 12, 16, and 20.
‡PFS was defined as the interval from randomization to the first documentation of definitive disease progression confirmed by an IRC or death from any cause; definitive disease progression of CLL was based on standard iwCLL criteria, other than lymphocytosis alone.3,8
§ORR was defined as the proportion of subjects who achieved a CR or PR. Responses were assessed by an IRC.3
||DoR was measured from the onset of first documented response (CR or PR) to disease progression or death.7
¶First planned interim analysis at 50% of events.3
#Most common (>15%) prior regimens: BR (45%), FCR (34%), R monotherapy (31%), FR (17%), and Chl monotherapy (16%).
**Baseline anemia was defined as a hemoglobin level <11 g/dL, baseline neutropenia as an absolute neutrophil count <1 x 109/L, and baseline thrombocytopenia as a platelet count <100 x 109/L.8
AC=anticoagulant; AP=antiplatelet; BID=twice daily; BR=bendamustine, rituximab; Chl=chlorambucil; CI=confidence interval; CIRS=Cumulative Illness Rating Scale; CR=complete response; CrCl=creatinine clearance; DoR=duration of response; FCR=fludarabine, cyclophosphamide, rituximab; FR=fludarabine, rituximab; HR=hazard ratio; IGHV=immunoglobulin heavy-chain variable region gene; IRC=independent review committee; iwCLL=International Workshop on Chronic Lymphocytic Leukemia; NCCN=National Comprehensive Cancer Network; NR=not reached; OS=overall survival; ORR=overall response rate; PFS=progression-free survival; po=orally; PR=partial response; R=rituximab.