Menu
Not yet recruiting NCT07643636

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

Phase II Interventional AML (Acute Myeloid Leukemia)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chidamide (Chi)+VAH.
Who it may be relevant to
Registry conditions: AML (Acute Myeloid Leukemia). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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 (Vene

Primary outcome measures

  • Composite Complete Remission Rate （CR+CRi） [Time frame: the First Induction Cycle （28days）]
Secondary outcome measures (6)
  • MRD negativity rate after the first induction cycle [Time frame: 28 days]
  • Composite CR/CRi rate after the second induction cycle [Time frame: 56 days]
  • 2-year overall survival (OS) rate [Time frame: 2 years]
  • 2-year relapse-free survival (RFS) rate [Time frame: 2 years]
  • Bridging Rate to Allo-HSCT [Time frame: 2 years]
  • Non-relapse mortality (NRM) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07643636 · CSIIT-A58

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗