Clinical Trial Goal
To find out:
- The highest dose of ziftomenib that's safe to give with standard treatment
- If the combination of ziftomenib and standard treatment is safe and works well to treat AML that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years or older
- Have AML that has relapsed or is refractory
- Have one of the following mutations or rearrangements:
- FLT3
- KMT2A
- NPM1
- Do not have any of the following:
- Acute promyelocytic leukemia
- Chronic myeloid leukemia in blast phase
- Do not have graft versus host disease (GVHD)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Cytarabine and fludarabine are chemotherapy (drugs) that block the growth of cancer cells.
Gilteritinib is a small molecule inhibitor that blocks FLT3 in certain cells.
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from treatment.
Idarubicin is a small molecule inhibitor that blocks topoisomerase II in certain cells.
Ziftomenib is a small molecule inhibitor that blocks MLL and Menin in certain cells.
In this trial, you’ll be randomized to 1 of 3 groups. Once you’re randomized, you’ll be told which group you’re in:
Gilteritinib is a small molecule inhibitor that blocks FLT3 in certain cells.
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from treatment.
Idarubicin is a small molecule inhibitor that blocks topoisomerase II in certain cells.
Ziftomenib is a small molecule inhibitor that blocks MLL and Menin in certain cells.
In this trial, you’ll be randomized to 1 of 3 groups. Once you’re randomized, you’ll be told which group you’re in:
- Group 1 – Ziftomenib plus cytarabine
- Group 2 – Ziftomenib plus gilteritinib
- Group 3 - Ziftomenib plus cytarabine, fludarabine, idarubicin and G-CSF
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Cytarabine - Group 1 and 3 only - Given as intravenous (IV) infusions
- Fludarabine - Group 3 only - Given as IV infusions
- Gilteritinib - Group 2 only - A pill that you take by mouth
- Granulocyte colony-stimulating factor - Group 3 only - Given as a shot under your skin
- Idarubicin - Group 3 only - Given as IV infusions
- Ziftomenib - A pill that you take by mouth
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 1 year.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat AML that has relapsed or is refractory is new and unproven.
Locations
Sponsors
lead: Kura Oncology, Inc.
