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.
Study Type
OBSERVATIONAL
Enrollment
37
The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity or resistance (dose range, 200-800 mg daily).
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGVariation of Gut Microbiota Composition and Diversity
Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during Sorafenib Maintenance Therapy.
Time frame: 3 months
Variation of gut barrier integrity
As determined by serum levels of zonulin, I-FABP, and citrulline or other potential candidates.
Time frame: 3 months
NRM
Non-relapse-mortality
Time frame: 1 year
Acute GVHD
Acute Graft-Versus-Host Disease
Time frame: 100 days
Chronic GVHD
Chronic Graft-Versus-Host Disease
Time frame: 1 year
AEs
Adverse Events
Time frame: 1 year
OS
Overall Survival
Time frame: 1 year
LFS
Leukemia-free Survival
Time frame: 1 year
Relapse
Cumulative incidence of relapse
Time frame: 1 year
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