Post-transplant azacitidine plus chidamide to prevent relapse in high-risk acute myeloid leukemia
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
This tests whether giving azacitidine together with chidamide after an allogeneic stem-cell transplant can help prevent relapse in adults (18–60) with high‑risk acute myeloid leukemia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guanzhou, Guandong) |
| Trial ID | NCT05270200 on ClinicalTrials.gov |
What this trial studies
This is a single-arm Phase 1/2 trial giving six 28-day courses of subcutaneous azacitidine (days 1–3 each cycle) combined with daily oral chidamide starting about 30 days after allogeneic stem-cell transplant, continuing chidamide for up to two years. Participants must have recovered blood counts to specified thresholds before starting and will stop treatment for severe cytopenias or grade 3–4 non-hematologic adverse events. Monthly visits include routine blood and urine tests, with bone marrow aspirates at months 1,2,3,4,5,6,9 and 12 and ECGs every three months. The study is designed to collect safety data and signals of relapse prevention in high‑risk AML post-transplant.
Who should consider this trial
Good fit: Adults aged 18–60 with non‑M3 AML who are high‑risk (poor genetics, primary refractory, relapsed, or secondary) after an allogeneic stem-cell transplant, with adequate organ function and blood counts, are the intended participants.
Not a fit: Patients with M3 AML, ongoing severe transplant complications or non-hematologic toxicity above Grade 2, persistent severe cytopenias, or those who cannot meet the blood‑count or organ‑function thresholds are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, this regimen could reduce post-transplant relapse and extend relapse-free survival for high‑risk AML patients.
How similar studies have performed: Maintenance azacitidine after allo-HSCT has shown mixed but sometimes promising results in reducing relapse, while combining azacitidine with the HDAC inhibitor chidamide is a newer approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guanzhou, Guandong
- Nanfang Hospital of Southern Medical University — Guanzhou, Guandong, China (Recruiting)
Study contacts
- Principal investigator: Rui Huang, Doctor — Zhujiang Hospital
- Study coordinator: Rui Huang, Doctor
- Email: Rachelchn@163.com
- Phone: +8615918528317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.