Post-remission treatments for MRD-positive adult AML

MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study

This study will try different drug regimens to see if they help people aged 14 and older with AML who are in remission but still MRD-positive stay relapse-free and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07131059 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Eligible patients are age 14 or older with non-M3 AML in morphological complete remission but with persistent MRD detected by flow cytometry, PCR (e.g., NPM1 or fusion genes), or NGS (e.g., FLT3), who can consent and be treated at the study site.

Not a fit: Patients unlikely to benefit include those planning immediate hematopoietic stem cell transplantation within four weeks, those with acute promyelocytic leukemia (M3/APL), or patients who are MRD-negative or medically ineligible for the study treatments.

Why it matters

Potential benefit: If successful, the approach could lower relapse rates and extend relapse-free and overall survival for MRD-positive AML patients after remission.

How similar studies have performed: Some targeted agents and MRD-guided approaches have shown promise in reducing relapse risk in AML, but a platform that adaptively compares multiple regimens in MRD-positive patients is relatively novel and not yet definitively proven.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

• 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

Conditions AML, Adult; Measurable Residual Disease