NCT07643636

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
35mo left

Started Jun 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Jun 2029

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

June 8, 2026

Last Update Submit

June 16, 2026

Conditions

AML (Acute Myeloid Leukemia)

Outcome Measures

Primary Outcomes (1)

  • Composite Complete Remission Rate （CR+CRi）

    the First Induction Cycle （28days）

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Chidamide , Venetoclax, Azacitidine, Homoharringtonine

EXPERIMENTAL
Drug: Chidamide (Chi)+VAH

Interventions

Chidamide (Chi)+VAHDRUG

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.

Chidamide , Venetoclax, Azacitidine, Homoharringtonine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.
  • Age ranging from 18 to 60 years, no restriction on gender.
  • 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.
  • Estimated overall survival ≥12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.
  • Renal function: calculated creatinine clearance (CrCl) ≥30 mL/min.
  • Hepatic function: alanine aminotransferase (ALT) \<5× upper limit of normal (ULN); total bilirubin \<3× ULN.
  • Able to provide written informed consent and understand as well as comply with all study-specified procedures.

You may not qualify if:

  • 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.
  • Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration.
  • Cardiac function exceeding NYHA functional class II.
  • 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.
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Zhangkun Li

CONTACT

0769-28637333lzk8239@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share