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