Clinical Trial Goal
To find out:
- The highest dose of ziftomenib that’s safe to give with standard therapy
- If the combination of ziftomenib and standard therapy is safe and works well to treat ALL that has not yet been treated in infants
You may be able to join this trial if you:
Your child:
- Is 0 - 1 years old
- Has ALL and has had little to no treatment
- Has cancer cells with mutation/marker CD19 (CD19+). Your child's doctor can tell you this
- Does not have any of the following:
- Acute myeloid leukemia (AML)
- Down Syndrome
- T-cell ALL (T-ALL)
- You agree to have other standard tests done to see if your child can be in the clinical trial
Trial Details
Blinatumomab is a bispecific T cell engager (BiTE) antibody that targets CD19 on certain cells.
Bortezomib is a small molecule inhibitor that blocks proteasome function in certain cells.
Mercaptopurine, methotrexate, pegaspargase are chemotherapy (chemo) drugs that block the growth of cancer cells.
Mitoxantrone is a drug that blocks topoisomerase II in certain cells.
Vorinostat is a small molecule inhibitor that blocks HDAC in some cancer cells.
Ziftomenib is a small molecule inhibitor that blocks MLL in certain cells.
Your child will get treatment in cycles that last 1 month. In each cycle, your child will get:
Bortezomib is a small molecule inhibitor that blocks proteasome function in certain cells.
Mercaptopurine, methotrexate, pegaspargase are chemotherapy (chemo) drugs that block the growth of cancer cells.
Mitoxantrone is a drug that blocks topoisomerase II in certain cells.
Vorinostat is a small molecule inhibitor that blocks HDAC in some cancer cells.
Ziftomenib is a small molecule inhibitor that blocks MLL in certain cells.
Your child will get treatment in cycles that last 1 month. In each cycle, your child will get:
- Blinatumomab – Given as intravenous (IV) infusions 1 time each day
- Bortezomib – Given as IV infusions. The dose your child will get depends on when they start the trial and how safe it has been
- Mercaptopurine – A pill that your child takes by mouth. The dose your child will get depends on when they start the trial and how safe it has been
- Methotrexate – Given as IV infusions. The dose your child will get depends on when they start the trial and how safe it has been
- Mitoxantrone – Given as IV infusions. The dose your child will get depends on when they start the trial and how safe it has been
- Pegaspargase – Given as IV infusions. The dose your child will get depends on when they start the trial and how safe it has been
- Vorinostat – A pill that your child takes by mouth. The dose your child will get depends on when they start the trial and how safe it has been
- Ziftomenib – A pill that your child takes by mouth. The dose your child will get depends on when they start the trial and how safe it has been
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 8 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using ziftomenib in this way to treat newly diagnosed ALL in infants is new and unproven.
Locations
Sponsors
collaborator: Pediatric Oncology Experimental Therapeutics Investigators' Consortium, collaborator: Amgen, collaborator: Lucile Packard Foundation for Children's Health, collaborator: Kura Oncology, Inc., collaborator: United States Department of Defense, collaborator: Cannonball Kid's Cancer, lead: Tanja Andrea Gruber
