Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or Refractory FLT3 -Mutated AML

PURPOSE Azacitidine plus venetoclax is a standard of care for patients with newly diagnosed AML who are unfit for intensive chemotherapy. However, FLT3 mutations are a common mechanism of resistance to this regimen. The addition of gilteritinib, an oral FLT3 inhibitor, to azacitidine and venetoclax may improve outcomes in patients with FLT3-mutated AML. METHODS This phase I/II study evaluated azacitidine, venetoclax, and gilteritinib in two cohorts: patients with (1) newly diagnosed FLT3-mutated AML who were unfit for intensive chemotherapy or (2) relapsed/refractory FLT3-mutated AML (ClinicalTrials.gov identifier: NCT04140487 ). The primary end points were the maximum tolerated dose of gilteritinib (phase I)…

• AP
  Astellas Pharma
• NI
  National Institutes of Health

  Awards: CA016672, P30 CA016672, CA100632
• UO
  University of Texas MD Anderson Cancer Center

  Awards: CA100632, CA016672, P30 CA016672
• NC
  National Cancer Institute

  Awards: P30 CA016672, CA016672, CA100632