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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Azacitidine

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 first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion.

4. Serum creatinine clearance rate is greater than 30ml/min.

Exclusion Criteria:

• 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