Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

Inclusion Criteria

• •1. The patient is ≥ 18 and ≤65 years old.
• •2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2.
• •3. The patient has adequate baseline organ function, including cardiac, renal, and hepatic function:
• •1. Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiography (ECHO) within 21 days before start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
• •2. ECG: QTcF≤450 male ≤480 female
• •3. Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of \> 50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
• •4. Bilirubin ≤3 times the upper limit of normal ULN mg/dL except for Gilbert's condition
• •5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)., except if due to leukemic involvement.
• •4. Patient is positive at diagnosis for FLT3 activating mutation in bone marrow or whole blood.
• •5. Diagnosis of untreated AML according to WHO 2016, non-APL
• •6. If the patient is a woman of childbearing potential (WOCBP), she must have a negative serum or urine pregnancy test at screening within 1 week before treatment.
• •7. The patient (male and female) agrees to use two acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for 6 months after the end of treatment
• •8. The patient has signed informed consent before initiation of any study-specific procedures or treatment.
• •9. The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment
• •5. Patient has had major surgery within 4 weeks prior to the first study dose.
• •6. Patient has radiation therapy within 4 weeks prior to the first study dose.
• •7. Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
• •8. Patient has an active uncontrolled infection.
• •9. Patient has active human immunodeficiency virus infection.
• •10. Patient has active hepatitis B or C or other active hepatic disorder. Chronic conditions previously cured or in active prophylaxis are allowed in the study
• •11. Patient has infections, comorbidities or any disease, condition or alteration that per judgment of the investigator may be jeopardized by therapy
• •12. Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of Hydroxyurea (HU) or 6-Mercaptopurine (6MP) in patients who need to continue this agent to maintain WBC count ≤10,000/mm3. HU and 6MP must be discontinued at the time of initiation of study medications.