Study of Venetoclax with Azacitidine to Treat Adults with Newly Diagnosed Acute Myeloid Leukemia in Colombia

What this Trial Is About

Researchers are studying adult patients in Colombia with acute myeloid leukemia AML, a type of blood and bone marrow cancer that is the most common acute leukemia in adults. This observational study evaluates how well venetoclax taken by mouth, combined with azacitidine given by injection, works for treating AML in real-life clinical practice. The trial is sponsored by AbbVie and aims to understand treatment effectiveness and safety. All participants will receive venetoclax tablets alongside azacitidine, administered either under the skin or through a vein, following approved local guidelines. Around 70 adults newly diagnosed with AML, who are either 75 years or older or younger adults with other health issues preventing intensive chemotherapy, will be enrolled. Treatment will be given according to routine medical care without additional study procedures. Participants will have study visits scheduled during their usual clinical care for approximately 36 months. Researchers will monitor overall survival up to 18 months, along with remission rates, transfusion independence, event-free survival, treatment duration, adverse events, minimal residual disease status, and quality of life changes. The study aims to gather data without imposing extra burden beyond standard treatment visits.

A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia