MRD-positive AML Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-11

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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AML, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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With lDH1 gene mutation

Ivosidenib 500mg/d d1-28 ；Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d:d1-28

Group Type EXPERIMENTAL

Ivosidenib

Intervention Type DRUG

500mg d1-28

Venetoclax

Intervention Type DRUG

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

FLT3 gene mutation

Gilteritinilb 120mg/d, d1 -28； Venetocax 400mg/d d1-28 400mg

Group Type EXPERIMENTAL

Gilteritinib

Intervention Type DRUG

120mg d1-28

Venetoclax

Intervention Type DRUG

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

NPM1 mutation or IDH2 mutation

Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d d1-21 or Cytarabine 20mg/m2/d d1-10；Venetoclax 600mg/d d1-21

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

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

c-kit mutation

Avapritinib 200mg/ day, 28 days a course

Group Type EXPERIMENTAL

Avapritinib

Intervention Type DRUG

200mg d1-28.

Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax

Cytarabine 100mg/m2/d, d1-5； Daunorubicin 45mg/m2/d，d1-2；or Idarubicin 10mg/ m2/d，d1-2；or MTZ 8mg/ m2/d d1-2; Venetoclax 400mg d1-7

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

45mg/m2/d d1-2;

Cytarabine

Intervention Type DRUG

100mg/m2/d d1-5

Idarubicin

Intervention Type DRUG

10mg/m2/d d1-2

MTZ

Intervention Type DRUG

8mg/m2/d d1-2

Cytarabine+HHT+Venetoclax

Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

100mg/m2/d d1-5

HHT

Intervention Type DRUG

2mg/m2/d d1-5

Venetoclax+Azacitidine/Venetoclax+Cytarabine

Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

100mg/m2/d d1-5

Azacitidine

Intervention Type DRUG

75mgd/m2 d1-7.

Interventions

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Ivosidenib

500mg d1-28

Intervention Type DRUG

Gilteritinib

120mg d1-28

Intervention Type DRUG

Venetoclax

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

Intervention Type DRUG

Avapritinib

200mg d1-28.

Intervention Type DRUG

Daunorubicin

45mg/m2/d d1-2;

Intervention Type DRUG

Cytarabine

100mg/m2/d d1-5

Intervention Type DRUG

Idarubicin

10mg/m2/d d1-2

Intervention Type DRUG

MTZ

8mg/m2/d d1-2

Intervention Type DRUG

HHT

2mg/m2/d d1-5

Intervention Type DRUG

Azacitidine

75mgd/m2 d1-7.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No