Actively Recruiting
MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-03-20
594
Participants Needed
2
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and agree to participate in the study
- Age between 14 and 70 years inclusive
- ECOG performance status score of 0 to 2
- Diagnosed with AML confirmed to have FLT3-ITD mutation
- Completed allogeneic hematopoietic stem cell transplantation (allo HSCT) with any donor or graft source
- Achieved complete morphological remission before allo HSCT with FLT3-ITD MRD positivity detected by PCR-NGS within 30 days before allo HSCT
- After transplantation, hematopoietic function restored (ANC 500/bcL, platelets 20000/bcL, not dependent on transfusions), complete donor chimerism, no acute graft-versus-host disease requiring prednisone >0.5 mg/kg daily
- Clinical labs: serum creatinine 2.0 times upper limit normal, total bilirubin 2.5 mg/dL excluding Gilbert syndrome, AST/ALT <3 times upper limit normal
- Maintenance treatment to start 60 to 90 days post-transplant
- Female participants must be menopausal, surgically sterilized, or agree to contraception during study and 6 months after; males must use contraception and not donate sperm during study and 127 days after last dose
You will not qualify if you...
- Allergy to gilteritinib, sorafenib, or study drug components
- Serious comorbid conditions affecting participation or protocol compliance
- FLT3-ITD molecular MRD positivity before maintenance therapy
- Severe organ dysfunction after allogeneic hematopoietic stem cell transplant
- Positive for hepatitis B with high HBV DNA, hepatitis C RNA positive, HIV positive, or positive syphilis test
- Severe infections or life-threatening complications within 6 months of enrollment
- Mental or neurological disorders preventing proper consent or communication
- Active malignant solid tumors within past 5 years except certain cured cancers
- Participation in another clinical trial within one month prior to enrollment
- Deemed unsuitable for the study by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
the First Affiliated Hosptital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
2
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
J
Jia Chen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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