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Trial Title:
The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
NCT ID:
NCT05596968
Condition:
Acute Myeloid Leukemia With FLT3/ITD Mutation
Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Sorafenib
Conditions: Keywords:
Hematopoietic Stem Cell Transplantation
Gut Microbiome
Sorafenib
FLT3-ITD
Acute Myeloid Leukemia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sorafenib
Description:
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).
Arm group label:
sorafenib group
Other name:
Nexavar
Other name:
BAY 43-9006
Other name:
BAY-673472
Other name:
BAY 545-9085
Summary:
This prospective trial investigates the effect of sorafenib maintenance therapy in
FLT3-ITD positive 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. 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.
Criteria for eligibility:
Study pop:
FLT3-ITD Positive AML undergoing allo-HSCT
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- FLT3-ITD Positive AML
- Allo-HSCT Recipients
Exclusion Criteria:
- intolerance to sorafenib pretransplantation
- 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Hematology,Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Xuan
Phone:
15521251270
Email:
356135708@qq.com
Start date:
October 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05596968
