This clinical trial is open to adult men and women age 60 and under who are newly diagnosed with FLT3 Mutated Acute Myeloid Leukemia (AML).
This study is being done to compare the effects, good and bad, of an investigational drug called crenolanib against midostaurin (RYDAPT®) in newly diagnosed acute myeloid leukemia patients with FLT3 mutations. Crenolanib is an investigational product, which means that it has not yet been approved for sale in the United States by the Food and Drug Administration (FDA). Midostaurin is approved by the FDA for the for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Subjects will be “randomized” into one of the study groups: crenolanib or midostaurin administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation. Randomization means that the subjects are put into a group by chance. It is like flipping a coin. The subjects will have a 50% (1 in 2) chance of receiving crenolanib, and a 50% chance (1 in 2) of getting midostaurin (RYDAPT®). Crenolanib and Midostaurin are taken orally (by mouth).
The estimated average time that a subject will receive study drug on this study is about 12-18 months. After that, subjects will be contacted by the research team every three months for up to 7 years.