Actively Recruiting
Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-26
134
Participants Needed
5
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with AML per WHO 2022 criteria and achieved first complete remission with intermediate/high-risk cytogenetic abnormalities at transplantation
- Achieved complete remission after stem cell transplantation
- Enrollment occurs between 60 and 100 days post-transplant
- ECOG performance status of 0 or 1
- Serum creatinine less than 1.5 times the upper limit of normal
- Serum direct bilirubin less than 1.5 mg/dL (except Gilbert's syndrome)
- ALT and AST less than 2.5 times the upper limit of normal
- Ability to understand and provide written informed consent
You will not qualify if you...
- Use of any other investigational drugs post-transplant
- Positive for FLT3 mutation
- Central nervous system involvement
- Uncontrolled grade 2 to 4 graft-versus-host disease
- Uncontrolled active infection
- Known or suspected allergy to Chidamide or its components
- Uncontrolled congestive heart failure or other severe systemic diseases or complications
- Pregnancy or breastfeeding
- Any other condition making participation unsuitable per investigator judgment
AI-Screening
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Trial Site Locations
Total: 5 locations
1
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
2
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
3
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
4
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
5
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
Research Team
J
Jiang Erlie, doctor
CONTACT
L
Liang Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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