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;