MRD-positive AML Clinical Study

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07131059
Status
Recruiting
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Conditions

  • AML, Adult

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivosidenib — DRUG
    500mg d1-28
  • Gilteritinib — DRUG
    120mg d1-28
  • Venetoclax — DRUG
    400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21
  • Avapritinib — DRUG
    200mg d1-28.
  • Daunorubicin — DRUG
    45mg/m2/d d1-2;
  • Cytarabine — DRUG
    100mg/m2/d d1-5
  • Idarubicin — DRUG
    10mg/m2/d d1-2
  • MTZ — DRUG
    8mg/m2/d d1-2
  • HHT — DRUG
    2mg/m2/d d1-5
  • Azacitidine — DRUG
    75mgd/m2 d1-7.

Study Details

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.

Key Dates

Start date
May 11, 2024
Status verified
May 2025
Primary completion
May 10, 2026
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: With lDH1 gene mutation
    Ivosidenib 500mg/d d1-28 ；Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d:d1-28
  • Experimental: FLT3 gene mutation
    Gilteritinilb 120mg/d, d1 -28； Venetocax 400mg/d d1-28 400mg
  • Experimental: 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
  • Experimental: c-kit mutation
    Avapritinib 200mg/ day, 28 days a course
  • Experimental: 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
  • Experimental: Cytarabine+HHT+Venetoclax
    Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7
  • Experimental: Venetoclax+Azacitidine/Venetoclax+Cytarabine
    Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21

Primary Outcome Measure

relapse-free survival rate [ Time Frame: up to 6 months ]

Central Contacts

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