NCT07304232

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

Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Allogeneic Hematopoietic Cell Transplantation (HCT)
• AML (Acute Myeloid Leukemia)

Interventions

Type	Name	Description
DRUG	Chidamide	Patients 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

5 sites across 1 country: China