Study
| Phase 2b, multicenter, randomized, open-label, noninferiority trial (NCT05177731) |
| Young (18–59 yrs), newly diagnosed, fit AML patients eligible for intensive chemotherapy |
| Venetoclax + decitabine (VEN-DEC) vs. idarubicin + cytarabine (IA-12) |
Efficacy
| CRc: 89% vs. 79% (VEN-DEC vs. IA-12) (noninferiority P = .0021) |
| MRD-negativity: 80% vs. 76% |
| 1-yr OS: 83.1% vs. 83.5% (HR: 1.15 [0.56-2.35]) |
| 1-yr EFS: 64.4% vs. 62.6% (HR: 0.91 [0.55-1.50]) |
| Subgroup – Adverse-risk AML: CRc 91% vs. 42% |
| Subgroup – RUNX1::RUNX1T1: CRc 44% vs. 88% |
Safety
| Grade ≥3 infections: 32% vs. 67% |
| Febrile neutropenia: 43% vs. 69% |
| Grade ≥3 pneumonia: 16% vs. 32% |
| Sepsis: 7% vs. 25% |
| Grade 4 thrombocytopenia duration: 13 days vs. 19 days |
| Red cell transfusions: 6 units vs. 10 units |
| Platelet transfusions: 25 units vs. 35 units |
| Early deaths (≤100 days): 1% vs. 4% |
Blood 2025;145:2645
http://doi.org/10.1182/blood.2024027217
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
