OncoMatch/Clinical Trials/NCT07463651
MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
Is NCT07463651 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Gilteritinib and Sorafenib for acute myeloid leukemia (aml).
Treatment: Gilteritinib · Sorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 ITD
confirmed to have FLT3-ITD mutation
Required: FLT3 ITD MRD positivity (transcript level ≥ 10^-6) detected by PCR-NGS within 30 days prior to allo HSCT (transcript level ≥ 10^-6)
FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT (defined as FLT3-ITD transcript level ≥ 10 - 6)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: allogeneic hematopoietic stem cell transplant
Successfully accepted allo HSCT
Lab requirements
Blood counts
anc ≥ 500/μl, platelet count ≥ 20000/μl and not dependent on infusion
Kidney function
serum creatinine ≤ 2.0 times the upper limit of normal value
Liver function
total bilirubin ≤ 2.5 mg/dl (excluding gilbert syndrome patients); serum ast and/or alt < 3 times the upper limit of normal values
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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