MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
Recruiting
Phase 3
Interventional Study
Acute Myeloid Leukemia (AML)
FLT3-ITD Mutation
Allogeneic Hematopoietic Cell Transplantation (HCT)
Maintenance Therapy
Gilteritinib
Sorafenib
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 14 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 594 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Other
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About This Trial
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 cont…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Informed consent and willingness to participate in this clinical study;
* Gender is not limited, age range is 14-70 years old (including threshold);
* ECOG score 0-2 points;
* Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molec…
Contacts