This trial is comparing the effect of crenolanib with midostaurin (Rydapt) in the treatment of acute myeloid leukemia. The main outcome to be measured is event-free survival (EFS - survival time after treatment with cancer not coming back or getting worse).
Acute myeloid leukemia (AML) is a cancer of the bone marrow. It is sometimes linked with abnormal genes. It is often treated with drugs which target certain proteins on cancer cells. It is important to research and compare drug treatments.
The study is searching for patients with AML to compare the effectiveness of crenolanib with midostaurin. Survival without signs of disease will be measured, as well as the duration of response to treatment and overall survival.
Who are they looking for?
510 patients with a new AML diagnosis are being recruited for this trial. Patients should have abnormal genes (FLT3-ITD and/or D835), and normal liver and kidney function.
Patients should not have liver disease, active infections, hepatitis B or C, or HIV. Patients with leukemia in the brain or those who have had previous cancer treatments will not be able to participate.
How will it work
There will be two groups in the study. One group will receive crenolanib orally, together with standard chemotherapy drugs cytarabine (Cytosar-U), daunorubicin (Cerubidine). The other group will receive oral midostaurin, with the same standard chemotherapy.
Event-free survival and duration of response will be measured up to 5 years. Overall survival will be measured up to 7 years.