Clinical trial NCT05596981: The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
Official title: The Gut Microbiome Changes in FMS-like Tyrosine Kinase 3 (FLT3)-ITD Positive Acute Myeloid Leukemia Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation With or Without Sorafenib Maintenance Post-transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia With FLT3/ITD Mutation
Allogeneic Hematopoietic Stem Cell Transplantation
Keywords: Hematopoietic Stem Cell Transplantation
Gut Microbiome
Sorafenib
Acute Myeloid Leukemia
FLT3-ITD
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FLT3-ITD Positive AML Undergoing Allo-HSCT

Brief summary: This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD AML patients after allo-HSCT in terms of gut microbiome.

Detailed description: 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. Recent studies show that gut microbiome is associated with graft-versus-host-disease (GVHD) and GVL. However, the exact mechanism of sorafenib enhancing the GVL effect and the influence of gut microbiome on sorafenib maintenance after allo-HSCT remain unknown.

Eligibility criteria: Inclusion Criteria:

* FLT3-ITD Positive AML
* Allo-HSCT Recipients

Exclusion Criteria:

* Intolerance to sorafenib pre-transplantation
* Cardiac 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)

Primary outcomes:
measure: Variation of Gut Microbiota Composition and Diversity
timeFrame: 3 months
Secondary outcomes:
measure: Variation of gut barrier integrity
timeFrame: 3 months
measure: NRM
timeFrame: 1 year
measure: Acute GVHD
timeFrame: 100 days
measure: Chronic GVHD
timeFrame: 1 year
measure: AEs
timeFrame: 1 year
measure: OS
timeFrame: 1 year
measure: LFS
timeFrame: 1 year
measure: Relapse
timeFrame: 1year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Li Xuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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