Study on the Safety and Effects of Pivekimab Sunirine with Venetoclax and Azacitidine for Treating Acute Myeloid Leukemia (AML)

Inclusion Criteria

• Have a new diagnosis of untreated Acute Myeloid Leukemia (AML) with a life expectancy of at least 12 weeks.
• Cancer cells must be CD123-positive.
• Not eligible for intensive chemotherapy due to age (75 or older) or other health conditions such as:
  • Moderate heart problems or low heart function.
  • Lung function issues.
  • Reduced kidney function.
  • Moderate liver problems.
  • Any other health condition that makes intensive chemotherapy unsuitable.
• Have a performance status score of 0 to 2 if 75 or older, or 0 to 3 if between 18 and 74.
• White blood cell count must be below a certain level before starting treatment.
• Must have adequate organ function, including:
  • Sufficient kidney function.
  • Liver function within specified limits.
  • Normal blood clotting times unless on stable anticoagulation.

Exclusion Criteria

• Have certain types of leukemia or other blood disorders.
• Have active cancer involvement in the central nervous system.
• Have had other cancers within the last 2 years, except for certain treated skin cancers or other localized cancers.
• Have previously received certain treatments for blood disorders or are currently in another clinical study.
• Women must not be pregnant or breastfeeding and must agree to use birth control during the study and for 7 months after. Men must also agree to use contraception if their partner is of childbearing potential.