The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects.
All patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results.
Study Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.
Informed consent and willingness to participate in this clinical study;
Gender is not limited, age range is 14-70 years old (including threshold);
ECOG score 0-2 points;
Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation;
Allergies to Girotinib or Sorafenib, as well as any components of the therapeutic drugs used during the study period;
Any serious comorbidities that make patients unsuitable for participation in this study or may affect protocol compliance;
FLT3-ITD molecular MRD positivity before maintenance therapy;
Severe organ dysfunction such as organ failure occurs after allogeneic hematopoietic stem cell transplantation;
Parallel
Gilteritinib
DrugRandomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take Gilteritinib 3 tablets (40 mg per tablet) daily in the morning, with continuous daily administration.
Sorafenib
DrugRandomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take sorafenib 400 mg orally, twice daily (BID), with continuous administration
Measurable residual disease recurrence-free survival (MRD-RFS)
The time from randomization to occurrence of hematological recurrence, molecular recurrence (FLT3-ITD mutation MRD changes from negative to positive), or death from any cause (whichever occurs first).
Overall Surivival (OS)
The time from randomazation to death
Molecular Recurrence
From random to MRD-positive detected by PCR NGS of FLT3-ITD mutation
MFC-MRD Recurrence
From randomization to MRD-positive detected by MFC
Cumulative Incidence of Relapse (CIR)
From randomization to relapse
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