NCT05270200RecruitingPhase 1/2
Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 Jan 2022
- Start date
- 1 Feb 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05270200
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Feb 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.