Actively Recruiting
Multicentre, Phase II Study of Chidamide as Post-transplant Maintenance Therapy in Intermediate/High-risk AML Patients
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-26
134
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of Chidamide as a maintenance therapy in patients with high-risk acute myeloid leukemia (AML) who have undergone stem cell transplantation. The study is a Phase II clinical trial designed to assess the impact of this treatment on recurrence-free survival, overall survival, and the duration of complete remission. It also examines the safety and tolerability of Chidamide and its effects on minimal residual disease in these patients. Participants in the trial are randomly assigned to one of two groups: an experimental group receiving Chidamide or an observation group without intervention. The Chidamide treatment involves taking 10 mg orally once daily for the first five days of each week, followed by two days off, in 28-day cycles. Treatment may continue for up to 24 months, with dose adjustments allowed to manage side effects. Patients may stay in the study even if relapse occurs, depending on clinical judgment. During the study, patients will be closely monitored through regular assessments including survival rates, response duration, and treatment-related side effects over a two-year period. The study also tracks changes in minimal residual disease and monitors safety using standard criteria. Participants will be followed until disease progression, unacceptable toxicity, or withdrawal from the study, ensuring comprehensive evaluation of the treatment's effects.
CONDITIONS
Brief Title
Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML per WHO 2022 criteria and achieved first complete remission with intermediate/high-risk cytogenetics at allogeneic transplantation
- Achieved complete remission after transplantation
- Enrollment between 60 and 100 days post-transplant
- Age between 18 and 75 years
- 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
- Able to understand and provide written informed consent
You will not qualify if you...
- Received other investigational drugs after transplantation
- 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 ingredients
- Uncontrolled congestive heart failure or severe systemic diseases that affect safety or assessment
- Pregnant or breastfeeding
- Any other condition judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive Chidamide orally at 10 mg/day for the first 5 days of each week, with a 2-day treatment-free interval. Treatment cycles are 28 days and continue for up to 24 months or until disease progression, intolerable toxicity, withdrawal, or other protocol-specified criteria.
Visits occur regularly for treatment and monitoring as determined by the investigator
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
L
Liang Chen
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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