Viewing Study NCT05601895



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Last Modification Date: 2024-10-26 @ 2:44 PM
Study NCT ID: NCT05601895
Status: RECRUITING
Last Update Posted: 2022-11-01
First Post: 2022-10-25

Brief Title: The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance
Sponsor: Nanfang Hospital Southern Medical University
Organization: Nanfang Hospital Southern Medical University

Study Overview

Official Title: The Gut Microbiome Changes in FMS-like Tyrosine Kinase 3 FLT3 Negative Acute Leukemia AL Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Allo-HSCT With or Without Sorafenib Maintenance Post-transplantation
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 negative acute leukemia patients after allo-HSCT in terms of gut microbiome
Detailed Description: Acute leukemia is a heterogeneous group of clonal diseases Leukemia relapse remains the main cause of treatment failure including the patients undergoing allogeneic hematopoietic stem cell transplantation allo-HSCT Sorafenib an inhibitor of multiple kinases including FLT3 has shown promising activity in FLT3-ITD-positive AML The investigators previous studies demonstrated that sorafenib maintenance post-transplantation could improve the outcomes of FLT3-ITD positive AML patients which was associated with sorafenib enhancing the graft-versus-leukemia GVL effect Recent studies have shown that sorafenib is also effective in patients with FLT3-negative acute leukemia The investigators previous exploratory study found that salvage therapy such as sorafenib combined with chemotherapy and donor lymphocyte infusion could significantly improve the CR rate and survival in patients with recurrent FLT3-negative acute leukemia after allo-HSC More and more studies have shown that sorafenib and allo-HSCT have synergistic GVL effect Some studies have demonstrated 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 in FLT3 negative acute leukemia patients remain 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