Clinical Trial Goal
To find out if quizartinib in combination with standard chemo is safe and works well to treat FLT3+ AML that has not yet been treated
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML that is FLT3+
- Do not have acute promyelocytic leukemia
- Do not have secondary AML
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Cytarabine, daunorubicin and idarubicin are chemotherapy (chemo) drugs that block the growth of cancer cells.
Quizartinib is a small molecule inhibitor that blocks FLT3 in certain cells.
In this trial, you’ll be randomized to 1 of 3 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
Quizartinib is a small molecule inhibitor that blocks FLT3 in certain cells.
In this trial, you’ll be randomized to 1 of 3 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – quizartinib plus standard chemo
- Group 2 – quizartinib plus placebo
- Group 3 - quizartinib plus standard chemo and placebo
Randomized means doctors will use a computer to assign you to a group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Cytarabine, daunorubicin or idarubicin (standard chemo) – Group 1 and 3 only - Given as intravenous (IV) infusions
- Placebo - Group 2 and 3 only - A pill with no medicine in it that you take by mouth 1 time each day
- Quizartinib - A pill that your take by mouth 1 time each day
You may continue treatment for up to 3 years. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for about 3.5 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat FLT3+ AML that has not yet been treated is new and unproven.
Contacts
Daiichi Sankyo Contact for Clinical Trial Information, 908-992-6400, CTRinfo_us@daiichisankyo.com
Locations
Sponsors
lead: Daiichi Sankyo
