Status:
RECRUITING
Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse
Lead Sponsor:
Zhujiang Hospital
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. Th...
Detailed Description
The Study Drug: Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may...
Eligibility Criteria
Inclusion
- Age 18 to 60 years old,both male and female
- Be able to understand and sign informed consent
- Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic
- Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML
- Patients with an ECOG performance status 0,1,2 or 3
- Expected survival time ≥ 3 months
- Non-hematological toxicity related to transplantation does not exceed Grade 2
- Laboratory indicators meet the following standards:
- 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.
- Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment.
- Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion.
- Serum creatinine clearance rate is greater than 30ml/min.
Exclusion
- Uncontrollable active infection
- Patients with active hepatitis B or C or HIV infection before enrollment
- Have a grade III-IV graft-versus-host disease
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05270200
Start Date
February 1 2022
End Date
December 31 2027
Last Update
September 25 2025
Active Locations (1)
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1
Nanfang Hospital of Southern Medical University
Guanzhou, Guandong, China, 510250