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NCT Number: NCT07131059

MRD-positive AML Clinical Study

This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

Hui Wei, MD

CONTACT

[email protected]

86-13132507161

About this study

Patients aged 14 years or older with diagnosed AML (non-M3) who have achieved complete remission in bone marrow morphology but are positive for minimal residual disease by flow cytometry or have the following genetic mutations that can be detected by PCR: NPM1 mutation, IDH1/2 mutation, DEK-NUP214 (DEK-CAN), RUNX1-RUNX1T1(AML 1-ETO), or CBFβ-MYH 11[4]. NGS can detect mutations such as FLT3.

For eligible patients, the treatment plan is selected by the doctor in charge according to the specific conditions of the patient. During the treatment, patients can have hematopoietic stem cell transplantation at any time.

This study compared relapse-free survival and overall survival of MRD-positive patients after effective and persistent MRD treatment, and based on the results, observed the efficacy and safety of different treatment regiments for MRD-positive AML patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ivosidenib

Drug

500mg d1-28

Gilteritinib

Drug

120mg d1-28

Venetoclax

Drug

400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21

Avapritinib

Drug

200mg d1-28.

Daunorubicin

Drug

45mg/m2/d d1-2;

Cytarabine

Drug

100mg/m2/d d1-5

Idarubicin

Drug

10mg/m2/d d1-2

MTZ

Drug

8mg/m2/d d1-2

HHT

Drug

2mg/m2/d d1-5

Azacitidine

Drug

75mgd/m2 d1-7.

Primary outcomes

  1. relapse-free survival rate

    Time frame: up to 6 months

Secondary outcomes

  1. Measurable Residual Disease

    Time frame: up to 6 months

  2. Proportion of MRD turning negative

    Time frame: up to 6 months

  3. Overall survival(OS ) rate

    Time frame: From the time the patients participated in the clinical trial until the patient died

  4. Cumulative relapse rate

    Time frame: From the time the patients participated in the clinical trial until the patient relapsed

  5. Adverse Events (AEs)

    Time frame: up to 2 years

  6. The incidence of adverse events such as serious infections during treatment

    Time frame: up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Wei, Doctor

CONTACT

[email protected]

13132507161

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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