A phase Ib trial that examined the safety and efficacy of

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IGHV 70 R/R (n = 20) 1L (n = 10) Age 63y (22?7) ORR 86 CR/CRi 41 BM MRD neg 53 (75 in pts with CR) Med f/u 17.5 Pregenual anterior cingulate cortex (ACC), suitable superior parietal gyrus (SPG), whereas months PFS 87 at 12 months PFS 84 at 24 months OS 94 at 12 months 5/6 pts with PD had RT 1 fatal TLS prior to protocol modification G3/4 AEs: neutropenia (53 ), thrombocytopenia (16 ), anemia (14 ), febrile neutropenia (12 ) No TLS events (lab and clinical) Schedule A is as safe as B in R/R pts. A ramp-up schedule of VEN up to 400 mg/d starting d22 of cycle 1 Ramp-up schedule to 400 mg/d 1L unfit pts (n = 13) CIRS > 6 or CrCl title= fnhum.2017.00272 It used the ramp-up dose schedule with the final dose set at 400 mg/day in the safety expansion phase, a dose that was well tolerated in the combination. Rituximab was given every 4 weeks for a total of 6 doses, after the VEN dose escalation. Patients hadhttp://tah.sagepub.comTable title= scan/nsw074 1. Venetoclax in chronic lymphocytic leukemia: clinical trial data summary.Design R/R Del(17p) ?31/102 (30 ) F-refractory - 70 (60 ) ORR 79 CR/CRi 20 (expansion cohort data have not matured) Med f/u 14.7 months Med PFS 25 months (56 pts in dose-escalating cohort) G3/4 AEs: neutropenia (41 ), anemia (12 ), thrombocytopenia (12 ). TLS: 10 pts (18 ), clinical in 3, including 1 death Patient characteristics Response rates Survival measures Main AEs (>10 )StudyTreatment arms[Roberts et al. 2016]Monotherapy phase I/II phase I (n = 56). After protocol change, trial continued as phase II. Total n = 116 Age 68y (50?8) 2 (1?) prior Tx R-ref 29 F-ref 18 Del(17p) 20 Unm. IGHV 70 R/R (n = 20) 1L (n = 10) Age 63y (22?7) ORR 86 CR/CRi 41 BM MRD neg 53 (75 in pts with CR) Med f/u 17.5 months PFS 87 at 12 months PFS 84 at 24 months OS 94 at 12 months 5/6 pts with PD had RT 1 fatal TLS prior to protocol modification G3/4 AEs: neutropenia (53 ), thrombocytopenia (16 ), anemia (14 ), febrile neutropenia (12 ) No TLS events (lab and clinical) Schedule A is as safe as B in R/R pts. G3/4 AEs: neutropenia (57 ), thrombocytopenia (17 )Therapeutic Advances in Hematology 7(5)[Ma et al. 2015]VEN-R phase Ib n =Phase I. Single dose of VEN on week 1, day ? or ? followed by continuous once-daily dosing from week 1, day1, until disease progression or unacceptable toxicity Trial continued as phase II, with weekly dose increases from 20, 50, 100, 200 mg to the final recommended dose of 400 mg daily VEN: ramp-up dose schedule, to a final dose of 200?00 mg/day R: every 4 weeks for a total of 6 doses; 400 mg selected to move forward[Salles et al.