Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05596968
Status:
RECRUITING
Last Update Posted:
2022-10-27
First Post:
2022-10-25
Brief Title:
The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
The Gut Microbiome and Sorafenib Maintenance Therapy in FMS-like Tyrosine Kinase 3 FLT3Internal Tandem Duplication ITD Positive Acute Myeloid Leukemia AML Patients After Allogeneic Hematopoietic Stem Cell Transplantation Allo-HSCT
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None