Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316960
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-12
Brief Title:
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
Sponsor:
Childrens Hospital of Soochow University
Organization:
Childrens Hospital of Soochow University
Study Overview
Official Title:
A Prospective Multicenter Clinical Study on The Safety and Efficacy of Avapritinib in The Treatment of RelapsedRefractory Pediatric Core Binding Factor Acute Myeloid Leukemia CBF-AML With KIT Mutation
Status:
RECRUITING
Status Verified Date:
2024-08
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 and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation
Detailed Description:
This is a multicenter single-arm prospective and intervention trial About 30 of core binding factor acute myeloid leukemia CBF-AML patients still relapse under current treatment Some studies have found that KIT mutations especially the D816V mutation may predict relapse and decrease overall survival OS in CBF-AML Avapritinib has been approved for the treatment of gastrointestinal stromal tumors with KIT or PDGFRA mutations Avapritinib was also effective for the treatment of minimal residual disease in acute myeloid leukemia with t 821 and KIT mutation failing to immunotherapy after allogeneic hematopoietic stem cell transplantation in a single-center retrospective report 11 centers from China carry out the AVACBFKIT regimen including Avapritinib hypomethylating agents and low dose chemotherapy for the treatment of relapsed or refractory pediatric CBF-AML with KIT mutation The main focus of this study is to evaluate the efficacy and safety of avapritinib in the regimen
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