Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

Exclusion Criteria

• •History of allogeneic stem cell transplantation
• •Prior treatment with an anti-CD123-directed agent
• •Need for concurrent other cytoreductive chemotherapy
• •Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation)
• •Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
• •Antitumor therapy or investigational agent within 14 days or 5 half-lives of Cycle 1 Day 1.
• •Requirement, at the time of study entry, for concurrent steroids \> 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution
• •Use of immunosuppressant medications in the 2 weeks prior to Cycle 1 Day 1
• •Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to Cycle 1 Day 1
• •Known central nervous system (CNS) leukemia
• •Active uncontrolled infection (including, but not limited to viral, bacterial, fungal, or mycobacterial infection),
• •Known human immunodeficiency virus infection, unless all of the following criteria are met: CD4+ count ≥ 350 cells/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
• •Known, active, history of or current acute or chronic hepatitis B or C virus (HBV) infection (as evidenced by detectable HBV surface antigen and HBV DNA ≥ 500 IU/mL),
• •History of hepatitis C virus (HCV) infection, unless the infection has been treated and cured,
• •Active SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing for ongoing infection should follow local clinical practice guidelines/standards. Participants with a positive test result for ongoing SARS-CoV-2 infection, known asymptomatic infection, or suspected infection are excluded unless or until asymptomatic and with subsequent negative SARS-CoV-2 laboratory test.