Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia
This study is being done to answer the following question:
How effective is the investigational drug crenolanib compared to the FDA-approved drug midostaurin in newly diagnosed Acute Myeloid Leukemia (AML) patients with FLT3 mutations?
Crenolanib is a type of drug known as a Tyrosine Kinase Inhibitor (TKI). TKI is a pharmaceutical drug that inhibits tyrosine kinases, that is activated in cancer.
We are doing this study because we want to find out if this approach (using crenolanib) is better or worse than the usual approach (using midostaurin) for your AML. The usual approach is defined as care most people get for AML.
Acute Myeloid Leukemia (AML)
Eligible subjects must meet the following:
-Be between 18 and 60 years of age,
-Have been diagnosed with AML,
-Have a FLT3 (a receptor that can signal cells to grow) mutation - This will tested at a screening study visit.
18 - 60
Healthy Volunteers Needed
Duration of Participation
The estimated average time that a participant will receive study drug on this study is about 13 months. You may take study drug as long as there is clinical benefit (that is your leukemia does not progress) and you are able to tolerate the study drug. After you stop taking the study drug, you will be followed to see if you are alive and well, and to assess the status of your disease.
Your study doctor will assess your individual response to the study drug and your participation may be longer or shorter than the estimated average.
Clinical Trials Information Line
AROG Pharmaceuticals, Inc.