Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
NCT ID: NCT07304232
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
134 participants
INTERVENTIONAL
2025-09-01
2028-12-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chidamide treatment group
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.
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.
Observation group
Observation group
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Locations
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The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Fuxu Wang
Role: primary
Shengjin Fan
Role: primary
Lijuan Li
Role: primary
Xingli Zhao
Role: primary
Other Identifiers
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IIT2025057
Identifier Type: -
Identifier Source: org_study_id