Actively Recruiting
Post-transplant Optimization Using Ultra-high Sensitivity MRD Detection Comparing Gilteritinib Versus Sorafenib as Maintenance Therapy in FLT3-ITD Positive Acute Myeloid Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-03-20
594
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating maintenance therapies for patients with FLT3-ITD mutation-positive acute myeloid leukemia (AML) who have undergone allogeneic hematopoietic stem cell transplantation (HCT). This phase 3, open-label, randomized controlled trial compares two drugs, gilteritinib and sorafenib, to determine their effectiveness in preventing disease recurrence. The study includes 594 participants, all tested for minimal residual disease (MRD) using a central PCR-NGS method to ensure consistent results. Participants are randomly assigned in equal numbers to receive either gilteritinib or sorafenib as maintenance therapy starting between 60 and 90 days after stem cell infusion. Those in the gilteritinib group take three 40 mg tablets daily every morning, while those in the sorafenib group take 400 mg orally twice daily. The treatment phase lasts for two years, with continuous administration of the assigned drug. Throughout the study, participants undergo regular assessments including MRD testing to monitor disease recurrence and other safety evaluations. Researchers will track measurable residual disease recurrence-free survival as the primary outcome over two years, along with several secondary outcomes such as overall survival, relapse rates, and graft-versus-host disease incidence. Follow-up continues until death, withdrawal, or two years after treatment begins, whichever occurs first.
CONDITIONS
Brief Title
MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent and agree to participate in the study
- Age between 14 and 70 years old inclusive
- ECOG performance status score of 0 to 2
- Diagnosed with AML confirmed to have FLT3-ITD mutation by bone marrow tests
- Successfully received allogeneic hematopoietic stem cell transplantation (allo HSCT) with any donor or graft source
- Achieved complete remission before allo HSCT and have FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT
- After transplantation, have engrafted hematopoietic function with ANC ≥ 500/μL and platelet count ≥ 20000/μL, not dependent on transfusion
- Have complete donor chimerism and no acute graft-versus-host disease requiring prednisone dose >0.5 mg/kg daily
- Meet clinical laboratory criteria: serum creatinine ≤ 2.0 times upper limit, total bilirubin ≤ 2.5 mg/dL (except Gilbert syndrome), AST/ALT < 3 times upper limit
- Maintenance treatment to start 60 to 90 days after transplantation
- Female participants must be postmenopausal or surgically sterilized or agree to use effective contraception during and 6 months after the study; males and their partners must use contraception during and 127 days after the study
- Agree not to breastfeed or donate eggs/sperm during and for specified times after the study
You will not qualify if you...
- Allergy to gilteritinib, sorafenib, or any study drug components
- Serious comorbid conditions that make participation unsafe or affect compliance
- FLT3-ITD molecular MRD positivity before maintenance therapy
- Severe organ failure after transplantation
- Positive hepatitis B surface antigen with high HBV DNA titer unsuitable for study
- Positive hepatitis C antibodies with detectable HCV RNA
- HIV antibody positive
- Positive syphilis test
- Serious diseases or life-threatening complications within 6 months that interfere with trial evaluation, including uncontrolled infections, severe heart failure, unstable angina, recent myocardial infarction, or poorly controlled hypertension
- Mental or neurological disorders preventing informed consent
- Active malignant solid tumors within 5 years except certain treated cancers
- Participation in any other clinical trial within 1 month prior to enrollment
- Judged unsuitable by researchers for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants take either Gilteritinib or Sorafenib daily as maintenance therapy starting 60 to 90 days after their stem cell transplant, continuing daily administration to prevent disease recurrence.
Regular visits during treatment to monitor health and medication effects
Duration - Up to 2 years after treatment
Participants are followed to monitor for disease recurrence, survival, and any long-term effects after treatment ends.
Visits scheduled periodically for assessments
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
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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