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Not yet recruitingNCT07643636Updated Jun 18, 2026

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

A Phase 2 interventional study of Chidamide (Chi)+VAH in AML (Acute Myeloid Leukemia), sponsored by Dongguan People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Dongguan People's Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • AML (Acute Myeloid Leukemia)
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 46 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Dongguan People's Hospital is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Chidamide , Venetoclax, Azacitidine, Homoharringtonine

    Drug: Chidamide (Chi)+VAH

Interventions

  • DrugChidamide (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.

06

What researchers measure

Primary outcomes

  1. Composite Complete Remission Rate (CR+CRi)

    Time frame: the First Induction Cycle (28days)

Secondary outcomes

  1. MRD negativity rate after the first induction cycle

    Time frame: 28 days

  2. Composite CR/CRi rate after the second induction cycle

    Time frame: 56 days

  3. 2-year overall survival (OS) rate

    Time frame: 2 years

  4. 2-year relapse-free survival (RFS) rate

    Time frame: 2 years

  5. Bridging Rate to Allo-HSCT

    Time frame: 2 years

  6. Non-relapse mortality (NRM)

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07643636
Lead sponsor
Dongguan People's Hospital
Responsible party
Sponsor
First posted
Jun 11, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Jun 18, 2026

Study contacts

Zhangkun Li
Contact
lzk8239@163.com
0769-28637333

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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