MRD response-adapted treatment for 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 clinical trial evaluates the effectiveness and safety of a regimen that adapts allogeneic hematopoietic stem cell transplantation (allo-HSCT) based on measurable residual disease (MRD) response in patients with adverse-risk acute myeloid leukemia (AML). The study is open-label and randomized, focusing on patients who have achieved complete remission after one or two courses of induction chemotherapy. Given the high relapse rates in this patient population, the trial aims to improve long-term leukemia-free survival by tailoring post-chemotherapy treatment based on MRD levels. The trial is conducted at multiple hospitals in China, including Peking University People's Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Newly diagnosed AML;
2. Categorized into adverse-risk group according to ELN 2022 criteria;
3. 16-65 years of age at the time of diagnosis;
4. achieving CR after 1 or 2 courses of induction chemotherapies;

4\) ECOG PS score of 0 to 1 5) It needs consent from the patients or/and legal guardian, and signature on the Informed Consent.

Exclusion Criteria:

1. Newly diagnosed AML, but categorized into favorite- or intermediate-risk group according to ELN 2022 criteria;
2. \< 16 years, or older than 65 years at the time of diagnosis;
3. Achieving CR after 3 or more courses of induction chemotherapies, or could not achieve CR after induction chemotherapies;
4. ECOG PS score of 2 or more;
5. Patients with other comorbidities or mental diseases that influence the life safety and compliance of patients as well as affect informed consent, enrollment in the research, follow-up visit or result interpretation.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Xiaodong Mo — Peking University People's Hospital
• Study coordinator: Xiaodong Mo
• Email: moxiaodong@pkuph.edu.cn
• Phone: 86-10-88326001

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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.