Study on Tagraxofusp with Venetoclax and Azacitidine for Adults with Untreated CD123+ Acute Myeloid Leukemia Who Cannot Have Intensive Chemotherapy

Inclusion Criteria

• Have not received treatment for AML and have a confirmed diagnosis based on specific medical criteria.
• Have CD123 markers on leukemia cells.
• Cannot have intensive chemotherapy due to:
  • Being 75 years or older, or
  • Being 18 to 74 years old with certain health issues, such as:
    • Moderate to severe physical limitations (ECOG score of 2 or 3).
    • Reduced lung function.
    • Heart function below normal levels.
    • Reduced kidney function.
    • Liver problems with high bilirubin levels.
    • Any other health issue that makes intensive chemotherapy unsafe, as determined by the study team.
• Have an ECOG performance status of 0 to 2 if 75 years or older, or 0 to 3 if 18 to 74 years old.

Exclusion Criteria

• Have received any previous treatment for AML.
• Are able and willing to receive standard intensive chemotherapy.
• Have been treated for a previous blood disorder with certain medications or therapies, including:
  • Hypomethylating agents, Venetoclax, Tagraxofusp, or similar drugs.
  • CAR-T therapy or other experimental treatments.
• Have AML that has spread to the central nervous system.