NCT07304232 Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
| NCT ID | NCT07304232 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Allogeneic Hematopoietic Cell Transplantation (HCT) |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 134 participants in total. It began in 2025-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Patients must achieve complete remission (CR) post-transplantation. 3. Enrollment must occur between 60 and 100 days after transplantation. 4. Age 18 to 75 years. 5. ECOG performance status 0-1. 6. Serum creatinine \< 1.5 × ULN (upper limit of normal). 7. Serum direct bilirubin \< 1.5 mg/dL (except in Gilbert's syndrome). 8. ALT and AST \< 2.5 × ULN. 9. Ability to understand and provide written informed consent. Exclusion Criteria: 1. Receipt of any other investigational drugs post-transplantation. 2. FLT3 mutation-positive status. 3. Central nervous system (CNS) involvement. 4. Uncontrolled grade 2-4 graft-versus-host disease (GVHD). 5. Uncontrolled active infection. 6. Known or suspected hypersensitivity to Chidamide or its excipients. 7. 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. 8. Pregnancy or breastfeeding. 9. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07304232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Allogeneic Hematopoietic Cell Transplantation (HCT). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07304232 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07304232 currently recruiting?
Yes, NCT07304232 is actively recruiting participants. Contact the research team at jiangerlie@ihcams.ac.cn for enrollment information.
Where is the NCT07304232 trial being conducted?
This trial is being conducted at Shijiazhuang, China, Harbin, China, Tianjin, China, Tianjin, China and 1 additional location.
Who is sponsoring the NCT07304232 clinical trial?
NCT07304232 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 134 participants.