1 Study Matches
Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML) (PrE0905)
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for a particular change in AML of their leukemia cells (called a mutation) in a gene called FLT3.
There are three phases to the study, You will have physical exams, imaging, bone morrow aspiration and biopsy. You may receive treatment for approximately 9 months (Induction and Consolidation). After you have finished taking the study drug (gilteritinib or midostaurin), the study doctor will ask you to return for a follow-up visit about one month after your last dose of study therapy (End of Treatment).
CI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
18 year(s) or older
Inclusion Criteria:AML with FLT3 mutation status (includes signal ratio)
Verified confirmation that blasts are myeloid
Verified NPM1 mutation status
Must have an ECOG performance status of 0-3
Must have adequate organ function as measured by criteria
Exclusion Criteria:May not have M3 AML
May not have known active Central Nervous System (CNS) leukemia
Not a woman of childbearing potential (WOCBP) or who agrees to follow the contraceptive guidance
May not have a history of Long QT Syndrome
May not have evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or congestive heart failure