Clinical Trial Goal
To find out:
- The highest dose of ziftomenib that's safe to give with azacitidine and venetoclax
- If the combination of azacitidine, venetoclax and ziftomenib 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 2 - 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)
- You agree to have other standard tests done to see if your child can be in the clinical trial
Trial Details
Azacitidine is a drug that blocks the growth of cancer cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
Ziftomenib is a small molecule inhibitor that blocks KMT2A in certain cells.
Your child will get:
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
Ziftomenib is a small molecule inhibitor that blocks KMT2A in certain cells.
Your child will get:
- Azacitidine – 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
- Venetoclax – 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 – Given as intravenous (IV) infusions. 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 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 acute leukemia that has relapsed or is refractory in children, teens and young adults is new and unproven.
Locations
MD Anderson Cancer CenterRECRUITING
Houston, Texas
David McCall, MD, 713-792-6604, dmccall1@mdanderson.org
Sponsors
collaborator: Kura Oncology, Inc., lead: M.D. Anderson Cancer Center
