A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia

The goal of this clinical trial is to learn if avapritinib combined with standard induction therapy works to treat newly diagnosed adult acute myeloid leukemia (AML) patients with KIT mutations and t(8;21)(q22;q22.1); inv(16)(p13.1q22) or t(16;16)(p13.1;q22). It will also investigate the safety and tolerability of this combination therapy. The main questions it aims to answer are: To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of avapritinib combined with chemotherapy by Dose-limiting toxicity (DLT). Does this combination therapy improve the rates of minimal residual disease (MRD) negativity and long-term survival outcomes?

NCT Number	NCT07028073
Lead Sponsor	The First Affiliated Hospital of Soochow University
Conditions	Acute Myeloid Leukemia With T(8;21)(Q22;Q22), Acute Myeloid Leukemia With T(16;16)(P13;Q22), KIT Gene Mutation, Avapritinib
Enrollment	78 participants
Start Date	2025-05-15
Primary Completion	2027-05-15 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-19