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Clinical Trials in China / NCT07131059
Recruiting Not applicable

MRD-positive AML Clinical Study

NCT07131059 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Not applicable
Started
2024-05-11
Last updated
2026-08-10

Condition(s) studied

AML, Adult

Investigational drug(s) / intervention(s)

IvosidenibGilteritinibVenetoclaxAvapritinibDaunorubicinCytarabineIdarubicinMitoxantroneHomoharringtonineAzacitidineRuxolitinibTrametinib

Ivosidenib: 500mg d1-28

Gilteritinib: 120mg d1-28

Venetoclax: 400mg d1-21 ; 400mg d1-7; 400mg d1-28; 600mg d1-14

Avapritinib: 200mg d1-28.

Daunorubicin: 45mg/m2/d d1-2;

Cytarabine: 100mg/m2/d d1-5

Idarubicin: 10mg/m2/d d1-2

Mitoxantrone: 8mg/m2/d d1-2

Homoharringtonine: 2mg/m2/d d1-5

Azacitidine: 75mgd/m2 d1-7.

Ruxolitinib: 20 mg twice daily, 28-day cycle

Trametinib: 12 mg twice daily, 28-day cycle

Study summary

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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Blood Diseases Hospital Tianjin Tianjin Municipality Recruiting

On this site

📄 Venclexta (venetoclax) drug profile → 📄 Jakafi (ruxolitinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131059 on ClinicalTrials.gov ↗ ← All trials in China