Clinical Trial Goal
To find out:
- The highest dose of gilteritinib that’s safe to give with liposomal cytarabine-daunorubicin
- If the combination of gilteritinib and liposomal cytarabine-daunorubicin is safe and works well to treat FLT3+ AML that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML that has relapsed or is refractory
- Have leukemia cells with a FLT3 mutation. Your doctor can tell you this
- Have not been treated with gilteritinib
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Gilteritinib is a small molecule inhibitor that blocks FLT3 in certain cells.
Liposomal cytarabine/daunorubicin is a combination of 2 drugs: cytarabine and daunorubicin. Both are chemotherapy (chemo) drugs that block growth of cancer cells.
You’ll get:
Liposomal cytarabine/daunorubicin is a combination of 2 drugs: cytarabine and daunorubicin. Both are chemotherapy (chemo) drugs that block growth of cancer cells.
You’ll get:
- Cytarabine/daunorubicin – Given as an intravenous (IV) infusion 2 or 3 times each month. Each infusion takes 1.5 hours. The dose you'll get depends on when you start the trial and how safe it has been
- Gilteritinib - A pill that you take by mouth each day for about 2 weeks. The dose you'll get depends on when you start the trial and how safe it has been
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved gilteritinib and liposomal cytarabine/daunorubicin to treat AML. Using them together in this way is new and unproven.
Locations
Moffitt Cancer CenterRECRUITING
Tampa, Florida
Jhada-Kai Hunter, 813-745-0286, Jhada-Kai.Hunter@moffitt.org
Sponsors
collaborator: Jazz Pharmaceuticals, lead: H. Lee Moffitt Cancer Center and Research Institute
