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Clinical Trials in China / NCT05270200
Recruiting Phase 1/2

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

NCT05270200 · tracked via the Priya Life Science China tracker
Sponsor
Zhujiang Hospital
Phase
Phase 1/2
Started
2022-02-01
Last updated
2026-07-07

Condition(s) studied

Leukemia, Myeloid, Acute

Investigational drug(s) / intervention(s)

AzacitidineChidamide

Azacitidine: Patients will recieve six courses of azacitidine 50mg/m2 through a needle under skin on Days 1-3.Each course is 28 days long.

Chidamide: Patients will recieve oral chidamide 5mg per day for no more than 2 years.

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nanfang Hospital of Southern Medical University Guanzhou Guandong Recruiting

More Zhujiang Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05270200 on ClinicalTrials.gov ↗ ← All trials in China