The purposes of this study are to see if the study drugs venetoclax and gilteritinib can be safely and effectively combined for the treatment of patients with acute myeloid leukemia (AML) that has returned after prior treatment or has failed to respond to prior treatment and identify potential biomarkers.
Venetoclax has been approved by the United States (US) Food and Drug Administration (FDA) and other health authorities to treat specific types of blood cancers. Gilteritinib is approved for the treatment of FLT3 mutation positive relapsed or refractory AML and is currently approved by Pharmaceutical Medical Devices Agency (PMDA) in Japan as well as by the US FDA. However, the FDA or other regulatory agencies have not yet found Gilteritinib safe and/or effective to treat patients when combined with venetoclax. Therefore, the use of these study drugs in combination is investigational (experimental) for the purposes of this study.
This is the first study of venetoclax in combination with gilteritinib. Venetoclax in combination with gilteritinib may or may not work better than either drug alone.
Detailed eligibility will be reviewed when you contact the study team.