Key clinical point: Addition of venetoclax to intensive chemotherapy with cladribine, idarubicin, and high-dose cytarabine (CLIA regimen) was safe and feasible as frontline therapy in patients aged 65 years or younger with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
Major finding: Overall, 94% (95% confidence interval [CI], 83%-98%) had a composite complete response and 82% (95% CI, 68%-92%) achieved measurable residual disease negativity. At 12 months, the rates of duration of response, overall survival, and event-free survival were 74% (95% CI, 60%-92%), 85% (95% CI, 75%-97%), and 68% (95% CI, 54%-85%), respectively. The most common grade 3 or worse adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%).
Study details: Findings are from a cohort study from the phase 2 CLIA trial including 50 patients (age, 18-65 years) with newly diagnosed AML (90%), MDS (8%), or mixed phenotype acute leukemia (2%).
Disclosures: This study was supported by grants from the MD Anderson Cancer Center. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Kadia TM et al. Lancet Haematol. 2021 Aug 1. doi: 10.1016/S2352-3026(21)00192-7 .