Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04674345
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2020-12-14
Brief Title:
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3 Negative Acute Leukemia
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
The purpose of this study is to evaluate the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients
Detailed Description:
Sorafenib is a multikinase inhibitor that blocks multiple pathways involved in the development and progression of acute leukemia such as FLT3-ITD the RAS and RAF gene families KIT and the VEGF and PDGF receptors Recently two back-to-back randomized controlled trials both reveal that sorafenib maintenance after allo-HSCT could prevent relapse in patients with FLT3-ITD AML resulting in a survival benefit Sorafenib has also been explored in the treatment of acute leukemia without FLT3 mutations and shown promising results Currently relapse remains the major cause of transplant failure especially for high-risk and refractory acute leukemia patients Once patients relapse after allo-HSCT the prognosis is dismal Therefore prevention of relapse is of great importance to improve the prognosis Based on the current research status we plan to conduct a prospective multicenter phase 2 randomized controlled trial to explore the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients
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