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.
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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

Jia Chen, MD, PhD

+86-512-67781856

drchenjia@163.com

CONTACT