The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence.
The names of the study drugs involved in this study are:
* Tagraxofusp (a type of CD123-directed cytotoxin) * Azacitidine (a type of standard of care cytidine nucleoside analog) * Venetoclax (a type of standard of care BCL-2 inhibitor)
Age ≥ 18 years.
History of known diagnosis of Acute Myeloid Leukemia (including de novo, secondary or AML arising from MDS).
Subjects must be in CR, CRi, or CRh with <5% morphologic blasts in bone marrow
Any evidence of CD123+ by central assessment.
Prior treatment with CD123-targeted therapy
Known diagnosis of acute promyelocytic leukemia.
Subjects who received intensive anti-leukemic chemotherapy within 2 weeks from first dose of study. If on venetoclax, subjects must be off venetoclax for at least 5 days
Subjects pre-arranged for SCT are only excluded if it is imminent.
Jacqueline Garcia, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Stemline Therapeutics, Inc.
Collaborator
Break Through Cancer Foundation
Collaborator