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 mi

Trial Details

NCT ID
NCT07028073
Phase
PHASE1 / PHASE2
Sponsor
The First Affiliated Hospital of Soochow University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Group A (FIT): Avapritinib + IA regimen
  • Group B (UNFIT): Avapritinib + VA regimen
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • 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…

For full eligibility, visit ClinicalTrials.gov.

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