About this study
Infants with a type of blood cancer called acute lymphoblastic leukemia (ALL) often do not do as well as older children with the same disease. This is especially true for infants whose cancer cells have a change in a gene called KMT2A. The usual chemotherapy treatments have not worked well enough for these babies. These infants have a higher chance of the cancer coming back. They also have more side effects from treatment.
This study tests 2 new medicines, blinatumomab and venetoclax, to see if adding them to chemotherapy can help infants with ALL live longer and have fewer side effects. Blinatumomab is an immunotherapy. It helps the body's immune system find and kill leukemia cells. Venetoclax is a targeted therapy. It helps kill leukemia cells by blocking a protein that helps them survive.
All patients in the study will get a steroid medicine for 7 days to help reduce the cancer cells. Patients will then be tested to find out if their cancer has the KMT2A gene change.
- Infants with the gene change will get blinatumomab and chemotherapy. They will also be randomly assigned (like flipping a coin) to get treatment with or without venetoclax.
- Infants without the gene change will get chemotherapy and blinatumomab but no venetoclax.
Doctors want to know how safe venetoclax is and how well it works. This information will help them understand if venetoclax should become part of standard care for infant ALL in the future.
Eligibility overview
- Up to 1 year old
- Newly diagnosed B-cell acute lymphoblastic leukemia
- Leukemia cells must have CD19 on their surface.
- Must not have received chemotherapy before, except for a short course of steroids