This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation.
Trial 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.
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).
Parallel
Chidamide
DrugPatients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval.
Recurrence-Free Survival(RFS)
the rate from first dose administration until the first achievement of complete remission (CR) or complete remission with incomplete recovery (CRi), followed by either confirmed relapse or death from any cause, whichever occurs earlier.
Overall Survival (OS)
the 2-year survival rate since receiving maintenance treatment with Chidamide to death from any causes
Event-Free Survival (EFS)
the 2-year event-free survival since receiving maintenance treatment with Chidamide to death from any causes
Duration of Response (CRd)
the duration of remission in AML patients receiving maintenance treatment with Chidamide
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.The frequency and severity of adverse events were evaluated based on changes in various vital sign indicators and laboratory tests.
Click on the lead sponsor to view all of their trials.
