Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determined by the treating physician. Patients had received induction and/or consolidation therapy, achieved remission, and underwent stem cell transplantation. Study
Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).
• 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.