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

ConditionAML (Acute Myeloid Leukemia)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDongguan People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Chidamide (Chi)+VAH

    Drug

    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.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Chidamide , Venetoclax, Azacitidine, HomoharringtonineExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dongguan People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: