A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
such as gemtuzumab, can block cancer growth in different ways. Some block the ability of
cancer cells to grow and spread. Others find cancer cells and help kill them or carry
cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab
may kill more cancer cells. It is not yet known whether combination chemotherapy is more
effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid
leukemia.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab
to see how well they work compared with combination chemotherapy alone in treating young
patients with newly diagnosed acute myeloid leukemia.