Avapritinib in CBF-AML With KIT Mutations

Core Binding Factor Acute Myeloid Leukemia Clinical Trial

Official title: Avapritinib in Relapsed Refractory or MRD-positive CBF-AML With KIT Mutations

Status Recruiting

Clinical Trial Summary

AML with t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as CBF-AML. KIT mutations are common in CBF-AML, which have a worse prognosis.This study is aimed to evaluate the efficacy of Avapritinib, an highly specific inhibitor of the KIT gene, in CBF-AML with KIT mutations.

Clinical Trial Description

Acute Myeloid Leukemia (AML) with the chromosomal abnormality of t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as the Core Binding Factor AML (CBF-AML). KIT mutation is a common mutation in CBF-AML, which is more likely to relapse and have a worse prognosis.

Avapritinib is an oral tyrosine kinase inhibitor (TKI) with selective inhibitory activity against KIT and PDGFRA. Avapritinib has been approved by FDA for the treatment of gastrointestinal stromal tumors(GIST) with PDGFRA mutations and Advanced systemic mastocytosis (AdvSM). However, the efficacy of avapritinib in AML with KIT mutations is uncertain.

This prospective, multicenter clinical study of the efficacy and safety of avapritinib in relapsed refractory or molecular minimal residual disease (MRD)-positive AML with KIT mutations. ;

Related Conditions & MeSH terms

• Core Binding Factor Acute Myeloid Leukemia

• NCT number: NCT05821738
• Study type: Interventional
• Source: The First Affiliated Hospital of Soochow University
• Contact: Suning Chen
• Phone: +8613814881746
• Email: chensuning@sina.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Completion date: December 31, 2025