Condition: Acute Myeloid Leukemia (AML) · FLT3-ITD Mutation · Allogeneic Hematopoietic Cell Transplantation (HCT) · Sponsor: The First Affiliated Hospital of Soochow University
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.
This description comes directly from the study's public registry record.
Jia Chen, MD, PhD · +86-512-67781856 · drchenjia@163.com
Always discuss trial participation with your own doctor first.
| the First Affiliated Hosptital of Soochow University | Suzhou, Jiangsu, China | Recruiting |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai, Shanghai Municipality, China | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07463651