About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
1.Uncontrollable active infection
2.Patients with active hepatitis B or C or HIV infection before enrollment
3.Have a grade III-IV graft-versus-host disease
Trial design
Single group
Treatments tested in this trial
Azacitidine
DrugPatients will recieve six courses of azacitidine 50mg/m2 through a needle under skin on Days 1-3.Each course is 28 days long.
Chidamide
DrugPatients will recieve oral chidamide 5mg per day for no more than 2 years.
Treatment groups
Trial outcomes
Primary outcomes
Number of Paticipants With Adverse Events as a Measure of Safety
Safety were measured with respect to: 1. Safety measurements 2. Incidence of adverse events
One year cumulative incidence of relapse
Leukemia relapse base on morphoogy criterion
Secondary outcomes
Relapes-free Survival(RFS)
The time that a participant survives without relapes of the disease
Overall survival(OS)
The time that a participant survives without death
The cumulative Incidence rate of GVHD
acute GVHD and chronic GVHD diagnosis based on MIH criterion
Other outcomes
Single-cell sequencing
Single-cell sequencing was used to explore the potential mechanism of AZA combined with sidarbenamide to prevent recurrence after transplantation in patients with AML
Sponsors and contacts
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