AML, Adult
Conditions
Keywords
Measurable Residual Disease
Brief 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.
Detailed description
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.
Interventions
DRUGIvosidenib
500mg d1-28
DRUGGilteritinib
120mg d1-28
DRUGVenetoclax
400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21
DRUGAvapritinib
200mg d1-28.
DRUGDaunorubicin
45mg/m2/d d1-2;
DRUGCytarabine
100mg/m2/d d1-5
DRUGIdarubicin
10mg/m2/d d1-2
DRUGMTZ
8mg/m2/d d1-2
DRUGHHT
2mg/m2/d d1-5
DRUGAzacitidine
75mgd/m2 d1-7.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse-free survival rate | up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of MRD turning negative | up to 6 months |
| Overall survival(OS ) rate | From the time the patients participated in the clinical trial until the patient died |
| Measurable Residual Disease | up to 6 months |
| Adverse Events (AEs) | up to 2 years |
| The incidence of adverse events such as serious infections during treatment | up to 2 years |
| Cumulative relapse rate | From the time the patients participated in the clinical trial until the patient relapsed |
Countries
China
Contacts
Primary ContactHui Wei, Doctor
Outcome results
None listed