Post-transplant azacitidine plus chidamide to prevent relapse in high-risk acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.