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Recruiting
NCT05596981
The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
Conditions: Acute Myeloid Leukemia With FLT3/ITD Mutation, Allogeneic Hematopoietic Stem Cell Transplantation
Sex: All
Ages: 18 Years – 65 Years
Enrollment: 60
Sponsor: Nanfang Hospital of Southern Medical University
Location: China
Summary
This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD AML patients after allo-HSCT in terms of gut microbiome.
Eligibility Criteria
Inclusion Criteria:FLT3-ITD Positive AMLAllo-HSCT RecipientsExclusion Criteria:Intolerance to sorafenib pre-transplantationCardiac dysfunction (particularly congestive heart failure)Hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)Renal dysfunction (creatinine clearance rate < 30 mL/min)Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)Patients with any conditions not suitable for the trial (according to the investigators' decision)
Source: ClinicalTrials.gov (NCT05596981). StuddyBuddy aggregates publicly available trial information.