Initial Results of the Phase 2 Treatment-Naive Cohort in a Phase 1 b/2 Study of Obinutuzumab, Ibrutinib, and Venetoclax in Chronic Lymphocytic Leukemia

摘要

An ongoing phase lb/2 study is evaluating a novel triplet regimen of obinutuzumab, ibrutinib, and venetoclax in patients with CLL. The phase lb component enrolled 12 patients with relapsed/ refractory CLL to receive a regimen that included dose-escalated venetoclax. The phase 2 trial has enrolled 25 patients with relapsed/refractory CLL and 25 treatment-naive patients. At the 2017 ASH meeting, Dr Kerry Rogers presented initial results from the phase 2 study in treatment-naive patients.1 All enrolled patients had adequate organ function and bone marrow function. Exclusion criteria included uncontrolled autoimmune hemolytic anemia or thrombocytopenia, active Richter syndrome, central nervous system involvement, and use of warfarin or potent CYP3A4 inhibitors or inducers within 7 days before starting the study treatment.