A Phase II multicenter open-label trial of tagraxofusp (Tag) in combination with venetoclax and azacitidine (Ven/Aza) in adults with previously untreated CD123+ acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

Overall, the goal of this research study is to determine if tagraxofusp (Tag) in combination with venetoclax (Ven) and azacitidine (Aza) can safely treat cancer in patients who have not received treatment for their AML before (i.e., this study is the first time that their AML is treated). The study is divided into 2 parts, with different goals for each part.
The goal of Part 1 of this research study is to find the safest effective dose of the study drug, Tag, in combination with Ven and Aza, in the body that will be given to patients with AML.The goal of Part 2 is to obtain additional efficacy data to determine how well Tag stops or slows cancer growth in combination with Ven and Aza and to further describe the safety profile (side effects) of Tag in combination with Ven and Aza when administered at the dose determined from data generated in Part 1 of the study.
This study will also look at how Tag enters and leaves your body, and at certain proteins in your blood and bone marrow (how the amounts of them might change after receiving Tag, or might be related to how well Tag does or does not function against the cancer).