Chidamide maintenance after stem cell transplant for intermediate- or high-risk AML

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 Phase II, open-label randomized trial will compare oral chidamide maintenance to observation in patients who achieve remission after allogeneic hematopoietic cell transplantation, with about 67 patients planned per arm. Chidamide is given 10 mg once daily on days 1–5 each week in 28-day cycles, with dose reductions to 5 mg allowed and treatment continued for up to 24 months or until progression or intolerable toxicity. The study's main outcomes are recurrence-free survival and overall survival, with additional measurement of duration of complete remission and tolerability. Eligible adults (18–75) must enroll 60–100 days post-transplant and have intermediate- or high-risk cytogenetics, while patients with FLT3 mutations, CNS disease, uncontrolled GVHD, or active infection are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-/high-risk cytogenetic abnormalities at the time of allogeneic transplantation.
2. Patients must achieve complete remission (CR) post-transplantation.
3. Enrollment must occur between 60 and 100 days after transplantation.
4. Age 18 to 75 years.
5. ECOG performance status 0-1.
6. Serum creatinine \< 1.5 × ULN (upper limit of normal).
7. Serum direct bilirubin \< 1.5 mg/dL (except in Gilbert's syndrome).
8. ALT and AST \< 2.5 × ULN.
9. Ability to understand and provide written informed consent.

Exclusion Criteria:

1. Receipt of any other investigational drugs post-transplantation.
2. FLT3 mutation-positive status.
3. Central nervous system (CNS) involvement.
4. Uncontrolled grade 2-4 graft-versus-host disease (GVHD).
5. Uncontrolled active infection.
6. Known or suspected hypersensitivity to Chidamide or its excipients.
7. Uncontrolled congestive heart failure (CHF) or other concomitant systemic diseases or severe complications that, in the investigator's judgment, would make the patient unsuitable for participation in this study or would significantly compromise the proper assessment of the safety and toxicity of the prescribed regimen.
8. Pregnancy or breastfeeding.
9. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.

Where it's running

• Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting
• The Second Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Not yet recruiting
• The First Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Not yet recruiting
• Tianjin Medical University General Hospital
  Tianjin, Tianjin Municipality, China Not yet recruiting
• Tianjin People's Hospital
  Tianjin, Tianjin Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Jiang Erlie, doctor
• Email: jiangerlie@ihcams.ac.cn
• Phone: +86-15122538106

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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.