Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse
To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation：A Multicenter, Single-arm Study
Zhujiang Hospital
20 participants
Feb 1, 2022
INTERVENTIONAL
Conditions
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. The safety of this combination will also be studied.
Eligibility
Inclusion Criteria12
- 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:
- 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 Criteria3
- Uncontrollable active infection
- Patients with active hepatitis B or C or HIV infection before enrollment
- Have a grade III-IV graft-versus-host disease
Interventions
Patients will recieve six courses of azacitidine 50mg/m2 through a needle under skin on Days 1-3.Each course is 28 days long.
Patients will recieve oral chidamide 5mg per day for no more than 2 years.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05270200