Venetoclax-Decitabine in Untreated Elderly/Unfit AML

Acute myeloid leukemia (AML) is a highly fatal malignancy in China, with particularly poor outcomes in elderly patients. Low-intensity regimens yield low remission rates, and median overall survival (OS) typically remains under 6-9 months. Venetoclax (VEN) combined with hypomethylating agents (azacitidine or decitabine（DEC）) has emerged as a first-line therapy for these patients, significantly improving response rates and survival. However, challenges persist, including suboptimal complete remission (CR) rates, low Measurable Residual Disease（MRD） negativity, and tolerability issues with prolonged use. Recent studies suggest that a 3-day decitabine regimen combined with VEN may enhance efficacy and tolerability. Building on prior evidence and our institutional experience, we propose this study to evaluate an optimized dosing strategy of VEN plus decitabine in treatment-naïve elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.

NCT Number	NCT07117422
Lead Sponsor	The Second Hospital of Hebei Medical University Collaborators: Handan First Hospital
Conditions	AML, Adult
Enrollment	39 participants
Start Date	2025-01-17
Primary Completion	2026-01-30 (estimated)
Study Completion	2027-01-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-12