Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02474290
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2015-06-14
Brief Title:
Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Sorafenib for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3-ITD Positive Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2015-06
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:
The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant Allo-HSCT recipients with FLT3-ITD positive acute myeloid leukemia AML
Detailed Description:
Internal tandem duplication of FMS-like tyrosine kinase 3 FLT3-ITD mutations have been reported in 20-30 of patients with acute myeloid leukemia AML FLT3-ITD-positive AML patients have an inferior survival primarily due to lower complete remission CR rate and higher relapse rate Although allogeneic hematopoietic stem cell transplantation allo-HSCT improves the outcomes of some FLT3-ITD-positive AML a significant number will suffer disease recurrence after allo-HSCT Sorafenib an inhibitor of multiple kinases including FLT3 has shown promising activity in FLT3-ITD-positive AML Recent studies have shown that sorafenib monotherapy or in combination with chemotherapy are effective in attaining CR but they do not have significant improvement in relapse Currently prophylactic use of sorafenib after allo-HSCT has been rarely reported and whether it can improve outcomes of FLT3-ITD-positive AML remains unclear
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None