Chidamide as maintenance treatment after stem cell transplant in higher-risk acute myeloid leukemia
Tests chidamide after stem cell transplant in adults with higher-risk acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
Key facts
- Where
- Harbin, Shijiazhuang, and Tianjin, ChinaSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with intermediate- or high-risk acute myeloid leukemia (AML) who are in remission after a stem cell transplant. It tests Chidamide as maintenance treatment.
- Age
- 18 to 75 years
- Sex
- All sexes can join
- Disease stage
- AML with intermediate- or high-risk cytogenetic changes, in first complete remission at the time of the allogeneic transplant and still in complete remission after it. Enrollment is 60 to 100 days after transplantation.
- Earlier treatment
- Must have had induction chemotherapy, and possibly consolidation therapy, before an allogeneic stem cell transplant. Must not have had any other investigational drug after the transplant.
- Biomarker or test result
- FLT3 mutation-positive people cannot join.
Main reasons for not taking part
- FLT3 mutation-positive
- Central nervous system involvement
- Uncontrolled grade 2-4 graft-versus-host disease
- Uncontrolled active infection
- Pregnancy or breastfeeding
Read by machine on 13 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07304232, who can take part
Where in China
- The First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaContact: Shengjin FanNot yet recruiting
- The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Fuxu WangNot yet recruiting
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaContact: Jiang Erlie, doctorTaking people
- Tianjin Medical University General HospitalTianjin, ChinaContact: Lijuan LiNot yet recruiting
- Tianjin People's HospitalTianjin, ChinaContact: Xingli ZhaoNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07304232
- Record updated
- 26 December 2025
- Original description
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.Read full original descriptionShow less
Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
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).
Inclusion: 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: Receipt of any other investigational drugs post-transplantation; 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; Uncontrolled grade 2-4 graft-versus-host disease (GVHD); Uncontrolled active infection; Known or suspected hypersensitivity to Chidamide or its excipients; Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study; FLT3 mutation-positive status; Central nervous system (CNS) involvement; Pregnancy or breastfeeding.