OncoMatch/Clinical Trials/NCT07304232
Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
Is NCT07304232 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chidamide for allogeneic hematopoietic cell transplantation (hct).
Treatment: Chidamide — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: FLT3 mutation
FLT3 mutation-positive status [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: allogeneic hematopoietic cell transplantation
achieved first complete remission (CR) with intermediate-/high-risk cytogenetic abnormalities at the time of allogeneic transplantation
Cannot have received: investigational drug
Exception: post-transplantation only
Receipt of any other investigational drugs post-transplantation
Lab requirements
Kidney function
Serum creatinine < 1.5 × ULN
Liver function
Serum direct bilirubin < 1.5 mg/dL (except in Gilbert's syndrome); ALT and AST < 2.5 × ULN
Serum creatinine < 1.5 × ULN; Serum direct bilirubin < 1.5 mg/dL (except in Gilbert's syndrome); ALT and AST < 2.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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