Azacitidine and Chidamide After Stem Cell Transplant for Acute Myeloid Leukemia
Tests azacitidine with chidamide to help control acute myeloid leukemia after a stem cell transplant.
Plain-language title generated from the registry record
Registry title: Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse
Key facts
- Where
- Guanzhou, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 60 with high-risk acute myeloid leukemia (AML) who have had a stem cell transplant from a donor. It tests azacitidine with chidamide to help keep the leukemia from coming back.
- Age
- 18 to 60 years old.
- Sex
- Both men and women can join.
- Disease stage
- AML that is not type M3 (according to the 2016 WHO classification). It must be one of these: AML with poor genetic changes, primary refractory AML, relapsed AML, or secondary AML. Expected survival of at least 3 months. ECOG performance status 0, 1, 2 or 3.
- Earlier treatment
- Must have had an allogeneic hematopoietic stem cell transplant. Side effects of the transplant that are not blood-related must not be worse than Grade 2.
- Biomarker or test result
- Blood and organ tests must meet set limits within 7 days before treatment starts: bilirubin, ALT and AST below 3 times the upper limit of normal; neutrophils above 1.5×10/L without G-CSF; platelets above 80×10/L without platelet transfusion; creatinine clearance above 30ml/min.
Main reasons for not taking part
- Uncontrollable active infection
- Active hepatitis B or C infection before enrollment
- HIV infection before enrollment
- Grade III-IV graft-versus-host disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT05270200, who can take part
Where in China
- Nanfang Hospital of Southern Medical UniversityGuanzhou, ChinaContact: Rui Huang, DoctorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhujiang Hospital
- Trial code
- NCT05270200
- Record updated
- 7 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.