Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib

Trial Details

NCT ID
NCT05024552
Phase
PHASE1
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Gilteritinib
  • Vyxeos
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one prior line of AML directed therapy

For full eligibility, visit ClinicalTrials.gov.

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