UVA Health System, Cancer Center seeks children, adolescents, and young adults aged 1 month through age 29 with De Novo Acute Myeloid Leukemia (AML) for a research study.

Researchers are conducting the study to find out if adding an investigational drug called gemtuzumab (Mylotarg®) to the current standard AML treatment will result in more participants being cured without having bad side effects. In the course of the study, participants will receive Xrays, scans, heart and lung function tests, bone marrow tests, physical exams, blood and urine tests, and spinal taps. Participants will be assigned randomly to either Arm A, which is the current standard therapy for AML, or to Arm B, which is the current standard therapy with gemtuzumab (Mylotarg®). Arm A patients will receive chemotherapy in their vein and in their spinal fluid; Arm B participants will also receive chemotherapy in their vein and their spinal fluid. After 82 days of study treatment, patients may receive more chemotherapy or receive a stem cell transplant at a participating institution based upon results of tests of participants' leukemia cells and the response of participants' leukemia to the first part of the study treatment.

Treatment on this clinical trial takes approximately 6 to 8 months.

Compensation

No compensation is available for participation in this study.