Venetoclax Plus Hypomethylating Agent for 7- Versus 14- Versus 21- Versus 28-Day Cycles in Newly-Diagnosed Acute Myeloid Leukemia: ELN and Mayo Genetic Risk-Stratified Analysis in 540 Patients.

Authors

Sudhesh Kumar, Momna Warraich, Mahnoor Fatima, Kristen McCullough, Aref Al-Kali, Hassan B Alkhateeb, Kebede H Begna, Abhishek A Mangaonkar, Antoine N Saliba, Mark R Litzow, William Hogan, Mithun Shah, Mrinal M Patnaik, Animesh Pardanani, Talha Badar, James Foran, Jeanne Palmer, Cecilia Arana Yi, Ayalew Tefferi, Naseema Gangat

Published in

American journal of hematology. Sep 17, 2026. Epub Sep 17, 2026.

Abstract

Patients with newly-diagnosed acute myeloid leukemia (ND-AML) derive variable survival benefit from venetoclax (Ven) plus hypomethylating agent (HMA) therapy, and the optimal Ven duration across genetic risk groups remains undefined. Among 540 ND-AML patients receiving Ven-HMA at Mayo Clinic, outcomes were compared across Ven 7- (n = 33), 14- (n = 117), 21- (n = 96), and 28-day (n = 294) schedules during Cycle 1 and stratified by ELN 2024 and Mayo genetic risk groups. At a median follow-up of 37.7 months, allogeneic stem cell transplant (ASCT) rates were similar across Ven duration groups (15%, 18%, 18%, and 20% for 7-, 14-, 21-, and 28-day; p = 0.86). Median transplant-censored survival was comparable across Ven durations (13.3, 11.9, 16.8, and 13.2 months for 7, 14, 21, 28 days, respectively; p = 0.65), with outcomes driven by ELN risk (6.3, 11.5, 18.3 months for high, intermediate, low; p < 0.01) and Mayo genetic risk (6.9, 17.8 months, not reached; p < 0.01). Survival was comparable across Ven durations within ELN intermediate/low-risk and all Mayo risk groups. Among ELN high-risk patients, 14-day Ven was associated with inferior transplant-censored survival compared to 21- and 28-day schedules (p < 0.01). Notably, 30- and 60-day mortality were higher with shorter Ven schedules (7-day: 9%/18%; 14-day: 7%/15%) versus 28-day (2%/6%), which likely reflects treatment selection bias. In ND-AML, no significant difference in transplant-censored survival was observed across the 7-, 14-, 21-, and 28-day Ven schedules; prognosis was determined primarily by Mayo and ELN 2024 genetic risk rather than by Ven duration. Prospective trials are needed to establish risk-adapted Ven dosing strategies.

PMID:
42755126
Bibliographic data and abstract were imported from PubMed on 18 Sep 2026.

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