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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: AML (Acute Myeloid Leukemia)
• Intervention / Treatment: Drug: Chidamide (Chi)+VAH

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhangkun Li; Phone Number: 0769-28637333; Email: lzk8239@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.
2. Age ranging from 18 to 60 years, no restriction on gender.
3. No prior anti-AML systemic therapy after AML diagnosis; cytoreductive treatment (e.g., hydroxyurea or cytarabine at a daily dose <1.0 g) is permitted as exception.
4. Estimated overall survival ≥12 weeks.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.
6. Renal function: calculated creatinine clearance (CrCl) ≥30 mL/min.
7. Hepatic function: alanine aminotransferase (ALT) <5× upper limit of normal (ULN); total bilirubin <3× ULN.
8. Able to provide written informed consent and understand as well as comply with all study-specified procedures.

Exclusion Criteria:

1. Patients stratified as favorable-risk AML defined by NCCN Guidelines 2022, including cytogenetic aberrations: t(8;21)(q22;q22.1); RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11.
2. Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration.
3. Cardiac function exceeding NYHA functional class II.

4. Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to:

   • Uncontrolled or active systemic infection (viral, bacterial or fungal); ② Concurrent second primary malignancy requiring urgent clinical intervention.

6. Patients unable to receive oral chidamide and/or venetoclax administration. 7. Known hypersensitivity to any investigational product. 8. Pregnant or breastfeeding female subjects. 9. Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Chidamide , Venetoclax, Azacitidine, Homoharringtonine

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite Complete Remission Rate （CR+CRi）	the First Induction Cycle （28days）

Secondary Outcome Measures

Outcome Measure	Time Frame
MRD negativity rate after the first induction cycle	28 days
Composite CR/CRi rate after the second induction cycle	56 days
2-year overall survival (OS) rate	2 years
2-year relapse-free survival (RFS) rate	2 years
Bridging Rate to Allo-HSCT	2 years
Non-relapse mortality (NRM)	2 years

Collaborators and Investigators

• Sponsor: Dongguan People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide
• Other Study ID Numbers: CSIIT-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No