Post-remission treatments for MRD-positive adult 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 is a platform-style interventional study enrolling patients aged 14 and older with non-M3 AML who are in morphological complete remission but remain MRD-positive by flow cytometry, PCR, or NGS. Treating physicians select from a range of targeted agents and chemotherapy combinations (including ivosidenib, gilteritinib, venetoclax, avapritinib, and daunorubicin) that may be adapted as new evidence emerges. Patients may proceed to hematopoietic stem cell transplant at any time if clinically appropriate. The study compares relapse-free survival and overall survival and monitors safety across the different regimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* AML (non-M3) compliant with WHO (2016) standards;
* In morphological complete remission.
* Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.
* Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.

Exclusion Criteria:

* Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks
* The diagnosis is APL
* Those who were not considered suitable for inclusion by the researchers.

Where it's running

• Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Huui Wei, doctor — Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
• Study coordinator: Hui Wei, Doctor
• Email: weihui@ihcams.ac.cn
• Phone: 13132507161

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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.