Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
About this study
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).
- Condition
- Allogeneic Hematopoietic Cell Transplantation (HCT), AML (Acute Myeloid Leukemia)
- Tested
- Chidamide
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Who can join
- Age
- 18 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 18 years
- Maximum age: 75 years
- Study condition: Allogeneic Hematopoietic Cell Transplantation (HCT), AML (Acute Myeloid Leukemia)
- 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 9
- Receipt of any other investigational drugs post-transplantation.
- FLT3 mutation-positive status.
- Central nervous system (CNS) involvement.
- Uncontrolled grade 2-4 graft-versus-host disease (GVHD).
- Uncontrolled active infection.
- Known or suspected hypersensitivity to Chidamide or its excipients.
- 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.
- Pregnancy or breastfeeding.
- Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
Where
5 sites, 5 recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Contact
-
Jiang Erlie, doctor
+86-15122538106 jiangerlie@ihcams.ac.cn
-
Liang Chen
+86-13612043271 liangchen@ihcams.ac.cn
Potential match only. Final eligibility is determined by the study team.