NCT07117422

Venetoclax-Decitabine in Untreated Elderly/Unfit AML

Efficacy and Safety of Venetoclax Plus Decitabine in Elderly/Unfit Patients With Newly Diagnosed AML: A Multicenter Single-Arm Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: The Second Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• AML, Adult

Interventions

Type	Name	Description
DRUG	VEN + DEC	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

Timeline

• Start date: 2025-01-17
• Primary completion: 2026-01-30
• Completion: 2027-01-30
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: China