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
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.
• 1.Age 18 to 60 years old,both male and female
• 2.Be able to understand and sign informed consent
• 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic
• 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML
• 5.Patients with an ECOG performance status 0,1,2 or 3
• 6.Expected survival time ≥ 3 months
• 7.Non-hematological toxicity related to transplantation does not exceed Grade 2
• 8.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.