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The Gut Microbiome and Sorafenib Maintenance Therapy in FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Acute Myeloid Leukemia (AML) Patients After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD positive AML patients after allo-HSCT in terms of gut microbiome.
Hematopoietic stem cell transplantation (HSCT) is used as a potentially curative therapy for patients with hematopoietic malignancies. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Our previous studies demonstrated that sorafenib maintenance post-transplantation could improve the outcomes of FLT3-ITD-positive AML patients, which is associated with sorafenib enhancing the graft-versus-leukemia (GVL) effect. Some studies show that gut microbiome is associated with graft-versus-host-disease (GVHD) and GVL. However, the effect of gut microbiome on sorafenib maintenance after allo-HSCT remains unknown.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Start Date
October 1, 2022
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2024
Last Updated
October 27, 2022
37
ESTIMATED participants
Sorafenib
DRUG
Lead Sponsor
Nanfang Hospital, Southern Medical University
NCT07101588
NCT06093867
Data Source & Attribution
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