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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Induction regimen Venetoclax (VEN): Day1-10 Decitabine (DEC):20mg/m²/day, Day 2-4 20mg/m² every 8 hours, Day 5-6 FLT3 Inhibitors (for FLT3/ITD+ patients only): Sorafenib or Gilteritinib, Day 8-14 Post-Remission Treatment Venetoclax (VEN): 400 mg/day, Day 1-7 Decitabine (DEC): 20 mg/m² every 8 hours, Day 2-3 (Regimen repeated every 4-6 weeks) FLT3 Inhibitors (for FLT3/ITD+ patients only): Sorafenib or Gilteritinib, Day 8-14
The Second Hospital of Hebei Medical University
Hebei, China
RECRUITINGthe Complete Remission (CR) Rate after Cycle 1
Time frame: up to 42 days after treatment
Overall Survival (OS)
Time frame: Within 5 years after randomization
Relapse-Free Survival Rate (RFS)
Time frame: Within 5 years after randomization
Cumulative incidence of relapse
Time frame: Within 5 years after randomization
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