MRD-positive AML Clinical Study
- Conditions
- AML, Adult
- Interventions
- Registration Number
- NCT07131059
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description With lDH1 gene mutation Ivosidenib Ivosidenib 500mg/d d1-28 ；Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d:d1-28 With lDH1 gene mutation Venetoclax Ivosidenib 500mg/d d1-28 ；Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d:d1-28 FLT3 gene mutation Gilteritinib Gilteritinilb 120mg/d, d1 -28； Venetocax 400mg/d d1-28 400mg FLT3 gene mutation Venetoclax Gilteritinilb 120mg/d, d1 -28； Venetocax 400mg/d d1-28 400mg NPM1 mutation or IDH2 mutation Venetoclax Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d d1-21 or Cytarabine 20mg/m2/d d1-10；Venetoclax 600mg/d d1-21 c-kit mutation Avapritinib Avapritinib 200mg/ day, 28 days a course Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax 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 Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax Daunorubicin 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 Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax Cytarabine 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 Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax Idarubicin 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 Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax MTZ 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 Cytarabine+HHT+Venetoclax Venetoclax Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7 Cytarabine+HHT+Venetoclax Cytarabine Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7 Cytarabine+HHT+Venetoclax HHT Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7 Venetoclax+Azacitidine/Venetoclax+Cytarabine Venetoclax Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21 Venetoclax+Azacitidine/Venetoclax+Cytarabine Cytarabine Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21 Venetoclax+Azacitidine/Venetoclax+Cytarabine Azacitidine Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21
- Primary Outcome Measures
Name Time Method relapse-free survival rate up to 6 months
- Secondary Outcome Measures
Name Time Method Measurable Residual Disease up to 6 months The incidence of adverse events such as serious infections during treatment up to 2 years 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 Cumulative relapse rate From the time the patients participated in the clinical trial until the patient relapsed Adverse Events (AEs) up to 2 years
Trial Locations
- Locations (1)
Blood Diseases Hospital
🇨🇳Tianjin, Tianjin, China
Blood Diseases Hospital🇨🇳Tianjin, Tianjin, ChinaHui Wei, MDContact86-13132507161weihui@ihcams.ac.cn