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NCT07643636Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (estimated)
First submitted
8 Jun 2026
Start date
30 Jun 2026
Primary completion date
1 Jun 2028
Lead sponsor
Dongguan People's Hospital
NCT number
NCT07643636

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 46
  • From 30 Jun 2026 to the primary completion date, 1 Jun 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Cardiac function exceeding NYHA functional class II.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.