Clinical Trial Goal
To find out:
- The highest dose of ziftomenib that's safe to give with standard chemo
- If the combination of ziftomenib and standard chemo is safe and works well to treat acute leukemia that has relapsed or is refractory in children, teens and young adults
You may be able to join this trial if you:
Your child:
- Is 0 - 21 years old
- Has acute leukemia that has relapsed or is refractory. Some examples include:
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Mixed-phenotype acute leukemia (MPAL)
- Has cancer cells with mutation KMT2A-r, NPM1-m or NUP98-r
- Does not have any of the following:
- Acute promyelocytic leukemia (APL)
- Juvenile myelomonocytic leukemia (JMML)
- Down syndrome
- You agree to have other standard tests done to see if your child can be in the clinical trial
Trial Details
Cytarabine is a chemotherapy (chemo) drug that blocks the growth of cancer cells.
Fludarabine is a chemotherapy (chemo) drug that blocks the growth of cancer cells.
Ziftomenib is a small molecule inhibitor that blocks KMT2A in certain cells.
Your child will get treatment in cycles that last 1 month. In each cycle, your child will get:
Fludarabine is a chemotherapy (chemo) drug that blocks the growth of cancer cells.
Ziftomenib is a small molecule inhibitor that blocks KMT2A in certain cells.
Your child will get treatment in cycles that last 1 month. In each cycle, your child will get:
- Cytarabine – Given as intravenous (IV) infusions 1 time each day for 5 days
- Fludarabine – Given as IV infusions 1 time each day for 5 days
- Ziftomenib – A pill that your child takes by mouth 1 time each day
Your child may continue treatment for as long as the clinical trial doctors think it’s best for your child's health. Your child will have biopsies to see how well the treatment is working. The clinical trial doctors will check your child's health for up to 2 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat acute leukemia that has relapsed or is refractory in children, teens and young adults is new and unproven.
Contacts
Dr. Branko Cuglievan, (713) 563-1499, bcuglievan@mdanderson.org
Dr. Sarah Tasian, MD, (215) 590-2299, tasians@chop.edu
Locations
Sponsors
collaborator: Kura Oncology, lead: PedAL BCU, LLC
