MRD-positive AML Clinical Study
ConditionAML, Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Ivosidenib
Drug500mg d1-28
Gilteritinib
Drug120mg d1-28
Venetoclax
Drug400mg d1-21 ; 400mg d1-7; 400mg d1-28; 600mg d1-14
Avapritinib
Drug200mg d1-28.
Daunorubicin
Drug45mg/m2/d d1-2;
Cytarabine
Drug100mg/m2/d d1-5
Idarubicin
Drug10mg/m2/d d1-2
Mitoxantrone
Drug8mg/m2/d d1-2
Homoharringtonine
Drug2mg/m2/d d1-5
Azacitidine
Drug75mgd/m2 d1-7.
Ruxolitinib
Drug20 mg twice daily, 28-day cycle
Trametinib
Drug12 mg twice daily, 28-day cycle
Treatment groups
537 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: With lDH1 gene mutationExperimental treatment 3 interventions
Group B: FLT3 gene mutationExperimental treatment 3 interventions
Group C: NPM1 mutation or IDH2 mutationExperimental treatment 3 interventions
Group D: c-kit mutationExperimental treatment 2 interventions
Group E: Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +VenetoclaxExperimental treatment 5 interventions
Group F: Cytarabine+Homoharringtonine+VenetoclaxExperimental treatment 3 interventions
Group G: Venetoclax+Azacitidine/Venetoclax+CytarabineExperimental treatment 3 interventions
Group H: JAK2 or CSF3R T618I mutationExperimental treatment 2 interventions
Group I: N-RAS and NF1 mutationsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
relapse-free survival rate
Time frame
up to 6 monthsSecondary outcomes
1
Measurable Residual Disease
Time frame
up to 6 months2
Proportion of MRD turning negative
Time frame
up to 6 months3
Overall survival(OS ) rate
Time frame
From the time the patients participated in the clinical trial until the patient died4
Cumulative relapse rate
Time frame
From the time the patients participated in the clinical trial until the patient relapsedSponsors and contacts
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Source ClinicalTrials.gov