A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)

Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy. Pivekimab sunirine is a drug

Trial Details

NCT ID
NCT07581002
Phase
PHASE2 / PHASE3
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Pivekimab Sunirine
  • Venetoclax
  • Azacitidine
  • Matching Placebo for PVEK
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Tampa, Florida, United States|27.94752,-82.45843
  • Atlanta, Georgia, United States|33.749,-84.38798
  • St Louis, Missouri, United States|38.62727,-90.19789
  • The Bronx, New York, United States|40.84985,-73.86641

Key Eligibility Criteria

  • Participants must have newly diagnosed, untreated confirmed acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organizat…
  • CD123-positive
  • Ineligible for intensive induction therapy (chemotherapy) defined by:
  • ≥ 75 years of age OR

For full eligibility, visit ClinicalTrials.gov.

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