About this study
This study will enroll infants up to 1 year of age who have acute lymphoblastic leukemia (ALL). ALL is a cancer of the white blood cells. Most children over age 1 who have ALL are cured. This is not true for infants with ALL, as less than half are cured.
Some doctors have used special treatments for infants with ALL. Other doctors have treated infants with the same treatments used in older children. Infants in this study have leukemia cells that may have a mutation in a gene called MLL (mixed lineage leukemia). This mutation is common in infants with ALL. Infants and children with this type of leukemia tend to have a high risk of relapse (leukemia returns). Most do not respond well to current treatments. In this study, doctors will use a new approach. They will add two new anti-cancer drugs called bortezomib and vorinostat to the standard ALL treatment.
Purpose of this clinical trial
The purpose of this study is to test the good and bad effects of the anti-cancer drugs bortezomib and vorinostat when given with chemotherapy commonly used to treat ALL in children. The drugs have been approved by the US Food and Drug Administration to treat other cancers in adults, but they have not been approved for treating children with leukemia. Doctors will gather details about the therapy’s side effects. They hope to learn more about the biology and genetics of infant ALL by studying blood and bone marrow samples. Doctors will also find better ways to measure minimal residual disease (MRD) in infants with ALL.