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

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

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

Treatments tested in this trial

  • Chidamide (Chi)+VAH

Treatment groups

46 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators