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Recruiting Phase 1, Phase 2 NCT05270200

Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse

Trial Parameters

Condition Leukemia, Myeloid, Acute
Sponsor Zhujiang Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2022-02-01
Completion 2027-12-31
Interventions
AzacitidineChidamide

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. The safety of this combination will also be studied.

Eligibility Criteria

Inclusion Criteria: * 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: 1. 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. 2. 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. 3. Measure twice within 7 days before the first day of the firs

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