Venetoclax-Decitabine in Untreated Elderly/Unfit AML
Status:
RECRUITING
Trial end date:
2027-01-30
Target enrollment:
Participant gender:
Summary
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 decitabineDEC) 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 DiseaseMRD 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-nave elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.