Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML

Chidamide : 10 mg/day, orally once daily (QD) on days 1-5 per week. During the study, the dose of chidamide may be adjusted at the physician's discretion to 5 mg/day. Each treatment cycle consists of 28 days. Treatment will continue indefinitely, with interruptions and dose adjustments implemented as needed to manage toxicity. Subjects will continue receiving the assigned treatment per investigator assessment for a maximum of 24 months, until documented disease progression, intolerable toxicity, withdrawal of consent, or meeting other protocol-specified criteria for treatment discontinuation (whichever occurs first). Patients who continue to derive clinical benefit, as discussed and agreed upon with the principal investigator, may remain in the study even in the event of relapse (if deemed clinically non-significant).

Inclusion criteria

• AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-/high-risk cytogenetic abnormalities at the time of allogeneic transplantation.
• Patients must achieve complete remission (CR) post-transplantation.
• Enrollment must occur between 60 and 100 days after transplantation.
• Age 18 to 75 years.
• ECOG performance status 0-1.
• Serum creatinine < 1.5 × ULN (upper limit of normal).
• Serum direct bilirubin < 1.5 mg/dL (except in Gilbert's syndrome).
• ALT and AST < 2.5 × ULN.
• Ability to understand and provide written informed consent.

Exclusion criteria

• Receipt of any other investigational drugs post-transplantation.
• FLT3 mutation-positive status.
• Central nervous system (CNS) involvement.
• Uncontrolled grade 2-4 graft-versus-host disease (GVHD).
• Uncontrolled active infection.
• Known or suspected hypersensitivity to Chidamide or its excipients.
• Uncontrolled congestive heart failure (CHF) or other concomitant systemic diseases or severe complications that, in the investigator's judgment, would make the patient unsuitable for participation in this study or would significantly compromise the proper assessment of the safety and toxicity of the prescribed regimen.
• Pregnancy or breastfeeding.
• Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.