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RECRUITING
NCT07117422
NA

Venetoclax-Decitabine in Untreated Elderly/Unfit AML

Sponsor: The Second Hospital of Hebei Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2025-01-17

Completion Date

2027-01-30

Last Updated

2025-08-12

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

The Second Hospital of Hebei Medical University

Hebei, China