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?
Age ≥18 years, both genders
Diagnosis of acute myeloid leukemia according to WHO 2022 criteria
Treatment-naive patients (hydroxyurea or low-dose cytarabine <0.5g cumulative dose allowed)
Bone marrow detection of KIT mutations with concurrent t(8;21)(q22;q22.1) or RUNX1::RUNX1T1 fusion gene; or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) or CBFβ::MYH11 fusion gene
Known hypersensitivity to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine or similar agents
Concurrent use of other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin)
Intracranial hemorrhage on imaging or unresolved prior intracranial bleeding
Active uncontrolled infection