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RECRUITING
NCT07463651
PHASE3

MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

14 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

594

Start Date

2026-05-01

Completion Date

2030-03-31

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

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

Locations (2)

the First Affiliated Hosptital of Soochow University

Suzhou, Jiangsu, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China