This trial is examining the effectiveness of crenolanib after salvage chemotherapy for relapsed or unresponsive acute myeloid leukemia (AML) with FLT3 activating mutations. The main outcome would be survival without complications from leukemia 3 years after the treatment has finished.
AML is a type of blood cancer. Some patients respond to treatment such as chemotherapy but the cancer returns and this is called relapsed AML. Some patients do not respond to treatment and this is called refractory AML. Both types of these patients are sometimes treated with salvage chemotherapy to kill cancer cells. Salvage chemotherapy usually involves a combination of drugs. Some AML types also have a characteristic which is called FLT3 activating mutations. Crenolanib may be able to help kill AML tumors with this characteristic because it blocks FLT3.
The purpose of this study is to see if crenolanib can improve the survival of patients with relapsed/refractory AML with FLT3 activating mutations who have been given salvage chemotherapy. The main outcomes will be to measure the survival and remission of patients 3 years after treatment.
Who are they looking for?
This study is recruiting 322 patients with relapsed or refractory AML after first-line or second-line treatment. Patients must have FLT3-ITD and/or D835 mutations. Patients should have good liver and kidney function.
Patients with leukemia in the brain cannot participate. Patients with severe liver disease or hepatitis B or C cannot participate. Patients should not have received treatment for leukemia 14 days before the trial starts or quizartinib or gilteritinib 21 days before the trial starts. Patients who have received crenolanib previously cannot participate.
How will it work
There will be two groups in this study. Both groups will receive salvage chemotherapy which is a combination of Cytarabine (Cytosar-U), Mitoxantrone (Novantrone), Fludarabine (Fludara), Idarubicin (Zavedos) and G-CSF (Neupogen). The first group will also be given crenolanib after the chemotherapy is completed, while the second group will receive a placebo after chemotherapy.
Survival will be measured for up to 3 years after the treatment has ended.