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

Inclusion 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
• •FLT3 testing must be confirmed at the time of disease relapse
• •Adequate organ function
• •Left ventricular ejection fraction (LVEF) ≥50%
• •Prior anthracycline exposure ≤368 mg/m2 daunorubicin (or equivalent)
• •Ability to take oral medication and willingness to adhere to the medication regimen
• •For females of reproductive potential: use of highly effective contraception including double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices and tubal ligation.
• •For females of reproductive potential: negative serum or urine pregnancy test with a sensitivity of at least 50mIU/mL within 10 days and again within 24 hours of beginning study treatment
• •For males of reproductive potential: use of condoms
• •Breastfeeding mothers must agree to discontinue nursing
• •Patients who have relapsed after and allogeneic stem cell transplant must have controlled grade ≤2 GVHD. Immunosuppression with tacrolimus or sirolimus is allowed at stable or tapering doses.