Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML

Inclusion Criteria: * • Histologically confirmed diagnosis of acute myeloid leukemia (AML) according per 2016 World Health Organization (WHO) criteria. * Cluster of differentiation marker (CD)33 and CD123 / interleukin (IL)3RA expression on the subject's blasts, determined by standard Flow AML MRD assay. * Age ≥ 12 * Relapsed or refractory after one cycle of prior therapy (cytoreductive agents such as hydroxyurea, cyclophosphamide, or a single dose of gemtuzumab ozogamicin are not considered prior treatment regimens). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 * Adequate baseline organ function, including cardiac, renal, and hepatic function as defined by: * Left ventricular ejection fraction (LVEF) ≥ 50% by multi-gated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) within 28 days prior to the start of therapy * No clinically significant abnormalities on a 12-lead electrocardiogram (ECG) * Creatinine Clearance (CrCl) ≥ 60mL/min * Serum albumin ≥ 3.2 g/dL (note that albumin infusions are not permitted in order to enable eligibility) * Total bilirubin ≤ 1.5 mg/dL * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN) * white blood cell (WBC) \< 20,000/uL on day of first therapy, cytoreduction may be achieved using hydroxyurea. * Ability to understand and willingness to sign a written informed consent document. * Able to adher…