Tagraxofusp to Eradicate Measurable Residual Disease in Patients With Acute Myeloid Leukemia

Prior treatment

• Intensive AML therapy within the past 14 days, or non-intensive targeted therapy within the past 7 days
• Any medical condition that in the opinion of the investigator places the participant at unacceptable risk for toxicity to investigational therapy

Other illness

• Second malignancy that would be expected to limit survival within less than 2 years
• Cardiovascular disease that would result in high risk for toxicity, including:
  • Uncontrolled or New York Heart Association (NYHA) class III or VI congestive heart failure
  • Recurrent or uncontrolled angina
  • Unstable angina, myocardial infarction, or stroke in past 6 months
  • Uncontrolled hypertension
  • Arrhythmia not controlled by medication
• History of coronary stent placement that requires mandatory continuation of dual antiplatelet therapy
• Uncontrolled intercurrent illness that includes but is not limited to: uncontrolled infection, disseminated intravascular coagulation, psychiatric illness/compliance issues that would limit compliance with study protocol

Lab values

• Left ventricular ejection fraction < 50%

Other

• MRD negativity < 0.01% at screening
• Cord blood as donor source

• Age >= 18 years
• AML in first or second remission, including:
  • Complete remission (CR), defined as bone marrow blasts < 5%, absence of circulating blasts, absence of extramedullary disease, absolute neutrophil count (ANC) >= 1,000/uL, platelet count > 100,000/uL
  • Complete remission with incomplete hematologic recovery (CRi), defined as all CR criteria except for residual neutropenia (ANC < 1,000/uL) or residual thrombocytopenia (platelet count < 100,000/uL)
  • Morphologic leukemia-free state with adequate marrow recovery, defined as bone marrow blasts < 5%, ANC >= 500/uL, and platelet count >= 20,000/uL
• Minimal residual disease positive >= 0.01% based on MPFC
  • For participants in first remission, MRD positivity at any point from time of establishing first remission onward while still in first remission
  • For participants in second remission, MRD positivity at any point from time of establishing second remission onward while still in second remission
  • MRD must be repeated and remain positive if additional treatment is given prior to enrollment
• CD123 positivity on flow cytometry (partial, dim, or bright) from either:
  • Conventional flow cytometry on marrow specimen from time of original diagnosis or first relapse
  • High-sensitivity multiparametric flow cytometry on marrow specimen from time of MRD positivity
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Serum albumin level >= 3.2 g/dL in the absence of receiving albumin infusion
• Serum total bilirubin =< 1.5 mg/dL, unless considered due to Gilbert's disease or medication effect
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase =< 2.5 times the upper limit of normal, unless considered due to medication effect (eg, azole therapy)
• Creatinine clearance >= 60 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) and serum creatinine (Cr) =< 1.8 mg/dL
• Ability to give full informed consent
• Females of reproductive potential (postmenopausal for less than 24 consecutive months) must have a negative pregnancy test within 1 week of initiating treatment and may not be breastfeeding