NCT07463651

MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib

Post-transplant Optimization Based on Ultra-high Sensitivity MRD Detection: A Prospective, Randomized Controlled Study Comparing Gilteritinib Versus Sorafenib as Post-transplant Maintenance Therapy in FLT3-ITD Mutation-positive Acute Myeloid Leukemia Patients

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 594 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Myeloid Leukemia (AML)
• FLT3-ITD Mutation
• Allogeneic Hematopoietic Cell Transplantation (HCT)
• Maintenance Therapy
• Gilteritinib
• Sorafenib

Interventions

Type	Name	Description
DRUG	Gilteritinib	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.
DRUG	Sorafenib	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

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-31
• Completion: 2030-03-31
• First posted: 2026-03-11
• Last updated: 2026-03-20

Locations

2 sites across 1 country: China