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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
594
Randomization 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.
Randomization 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
the First Affiliated Hosptital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGRuijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGMeasurable 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).
Time frame: 2-year
Overall Surivival (OS)
The time from randomazation to death
Time frame: 2-year
Molecular Recurrence
From random to MRD-positive detected by PCR NGS of FLT3-ITD mutation
Time frame: 2-year
MFC-MRD Recurrence
From randomization to MRD-positive detected by MFC
Time frame: 2-year
Cumulative Incidence of Relapse (CIR)
From randomization to relapse
Time frame: 2-year
Non-Relapse Mortality (NRM)
From randomization to death unrelated to AML
Time frame: 2-year
Chronic Graft-versus-Host Disease (cGVHD)
From randomization to the occurence of chronic graft-versus-host disease (cGVHD)
Time frame: 2-year
Acute Graft-versus-Host Disease (aGVHD)
From randomization to the occurence of acute graft-versus-host disease (aGVHD)
Time frame: 2-year
Graft-versus-Host Disease and Relapse-free survival (GRFS)
From randomization to the occurence of graft-versus-host disease (GVHD), relapse or death, which occurs first
Time frame: 2-year
Relpase-Free Survival (RFS)
From randomization to the occurence of relapse or death, which occurs first
Time frame: 2-year
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