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RECRUITINGINTERVENTIONAL

MRD-positive AML Clinical Study

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. willing to sign a consent form must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, willing to sign a consent form 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 willing to sign a consent form shall be signed by the legal guardian or the patient's immediate family. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Ivosidenib

500mg d1-28

DRUG

Gilteritinib

120mg d1-28

DRUG

Venetoclax

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

DRUG

Avapritinib

200mg d1-28.

DRUG

Daunorubicin

45mg/m2/d d1-2;

DRUG

Cytarabine

100mg/m2/d d1-5

DRUG

Idarubicin

10mg/m2/d d1-2

DRUG

MTZ

8mg/m2/d d1-2

DRUG

HHT

2mg/m2/d d1-5

DRUG

Azacitidine

75mgd/m2 d1-7.

Locations (1)

Blood Diseases Hospital
Tianjin, Tianjin Municipality, China