Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Adults ≥18 years of age with acute myeloid leukemia (AML) and at least 1 prior line of
therapy
- FMS-like tyrosine kinase 3 (FLT3)-mutated disease documented in a local reference
laboratory at the time of consideration for enrollment in the study
- Have the ability to understand the requirements and procedures of the study and sign a
written informed consent form
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- Adequate hepatic and renal function
- Prothrombin time (PT), activated partial thromboplastin time (aPTT) and international
normalized ratio (INR) ≤1.5x upper limit of normal (ULN) unless receiving therapeutic
anticoagulation
- Negative serum ß-human chorionic gonadotropin (HCG) test in women of child-bearing
potential (WOCBP)
- Left ventricular ejection fraction ≥50% confirmed by echocardiogram (ECHO) or
multi-gated acquisition (MUGA) scan
Exclusion Criteria:
- Known central nervous system (CNS) involvement with leukemia
- Clinical signs/symptoms of leukostasis that have failed therapy including hydroxyurea
and/or leukapheresis of at least 3 days duration
- Pregnant or breastfeeding women
- Active infection with hepatitis B, C or human immunodeficiency virus (HIV) infection
- Disseminated intravascular coagulation with active bleeding or signs of thrombosis
- Known active coronavirus disease 2019 (COVID-19)
- Administration of a live attenuated virus vaccine within 35 days before Cycle 1 Day 1
(C1D1)
- History of non-myeloid malignancy except for the following: adequately treated
localized basal cell, or squamous cell carcinoma of the skin, or localized melanoma
(with TNM stage either Tis [melanoma in-situ] or T1aN0M0) with complete resection;
cervical carcinoma in situ; superficial bladder cancer; asymptomatic prostate cancer
without known metastatic disease, with no requirement for therapy or requiring only
hormonal therapy and with normal prostate specific antigen for > 1 year prior to start
of study therapy; or any other cancer that has been in complete remission without
treatment for ≥3 years prior to enrollment
- Clinically significant heart disease
- Prolongation of the congenital long measure between Q wave and T wave in the
electrocardiogram (QT) interval at baseline
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection at the
time of study treatment initiation
- Current (within 30 days of study enrollment) drug-induced liver injury, chronic active
hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary
cholangitis with inadequate response to ursodeoxycholic acid or other health authority
approved therapy, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the
liver, orportal hypertension
- Ongoing (within 6 weeks of study enrollment) hepatic encephalopathy
- Ongoing immunosuppressive therapy, including systemic chemotherapy for treatment of
leukemia
