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NOT YET RECRUITING
NCT07643636
PHASE2

Chidamide, Venetoclax, Azacitidine, and Homoharringtonine for High-risk Fit AML

Sponsor: Dongguan People's Hospital

View on ClinicalTrials.gov

Summary

This study aims to explore a superior first-line induction remission regimen by incorporating Chidamide into the modified VAH chemotherapy combined with targeted therapy regimen, leveraging its dual epigenetic modulation mechanism.

Official title: A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the Treatment of Intermediate- to High-risk Fit AML Patients

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-06-30

Completion Date

2029-06-01

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DRUG

Chidamide (Chi)+VAH

Induction (Chi+VAH Regimen): Cycle 1: Chi+VAH regimen (28-day cycle). Assessment \& Cycle 2: CR/CRi: Repeat one cycle → Proceed to post-remission therapy. PR: Repeat one cycle → Re-assess. If CR/CRi → Proceed to post-remission therapy. NR: Discontinue study. Post-Remission / Consolidation: 1-2 cycles of either intermediate-dose Cytarabine (± targeted therapy) OR the Chi+VAH regimen. Eligible patients should proceed to allogeneic HSCT. Maintenance (Non-transplant): MRD-negative: VA (Venetoclax + Azacitidine) until relapse, intolerance, or 1 year. MRD-positive: Chi+VAH or clinical trial until MRD negativity, then switch to VA maintenance.