Clinical Trial Goal
To find out:
- The highest dose of ziftomenib that’s safe to give
- If ziftomenib, alone or with midazolam or itraconazole, is safe and works well to treat acute leukemia that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have acute leukemia that has relapsed or is refractory and there are no standard treatments available
- Do not have acute promyelocytic leukemia
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Midazolam is a benzodiazepine that doctors think can help improve leukemia with MEIS1 expression.
Itraconazole is an antifungal that doctors think can target leukemia with MEIS1 expression.
Ziftomenib is a small molecule inhibitor that blocks MLL and Menin in certain cells.
In this trial, you’ll be placed into 1 of 3 groups based on your genetics:
Itraconazole is an antifungal that doctors think can target leukemia with MEIS1 expression.
Ziftomenib is a small molecule inhibitor that blocks MLL and Menin in certain cells.
In this trial, you’ll be placed into 1 of 3 groups based on your genetics:
- Group 1 – Ziftomenib
- Group 2 – Ziftomenib plus midazolam
- Group 3 – Ziftomenib plus itraconazole
You’ll get:
- Midazolam - Group 2 only - A pill that you take by mouth
- Ziftomenib – A pill that you take by mouth 1 time each day. The dose you’ll get depends on when you start the trial and how safe it has been
- Itraconazole - Group 3 only - A pill that you take by mouth
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 treatment is working. After you finish treatment, the clinical trial doctors will check your health for 1 year.
The Food and Drug Administration (FDA) approved all of the drugs used in this trial. Using them in this way to treat acute leukemias with particular genetic expressions is new and unproven.
Locations
Sponsors
lead: Kura Oncology, Inc.
