This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or refractory acute myeloid leukemia or acute promyelocytic leukemia. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PRIMARY OBJECTIVES: I. To provide patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL), who have relapsed or who are refractory to standard treatments, with access to gemtuzumab ozogamicin (Mylotarg) when no other comparable or satisfactory alternative therapy is available. II. To carefully monitor safety and to report safety information from patients receiving Mylotarg in this setting. OUTLINE: Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15. After completion of study treatment, patients are followed up every month for 1 year.
Study Type
EXPANDED_ACCESS
Given IV
Correlative studies
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
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