|The goal of the Phase I part of this clinical research study is to test 2 dose |
levels of the drug inotuzumab ozogamycin to find the highest tolerable dose
that can be given in combination with chemotherapy. The goal of Phase II is to
learn if inotuzumab ozogamycin given in combination with chemotherapy can help
to control ALL. The safety of the study drugs will also be studied.
Inotuzumab ozogamycin is designed to attach to a protein that is often found in
leukemia cells. This may cause the cancer cells to die.
Rituximab is designed to attach to cancer cells and damage them, which may
cause the cells to die.
Hyper-CVAD includes a combination of cyclophosphamide, vincristine,
dexamethasone, methotrexate, Ara-C (cytarabine), and Neulasta (pegfilgrastim).
The maintenance therapy used in this study is called POMP, which includes a
combination of mercaptopurine, methotrexate, vincristine, and prednisone.
These chemotherapy drugs are designed to interfere with the multiplication of
cancer cells, which may slow or stop their growth and spread throughout the
body. This may cause the cancer cells to die.