NCT07304232RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 5 Sept 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07304232
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 134
- From 1 Sept 2025 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- FLT3 mutation-positive status.
- Central nervous system (CNS) involvement.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Tianjin People's Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.