Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS

Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years.

To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.

Patients eligible for treatment will receive the following:

Mylotarg at 6 mg/m2 on day 1 as a 2 hour intravenous infusion

Cytarabine at 100 mg/m2/day as a continuous intravenous infusion daily for 7 days

Inclusion Criteria:

• Histologic diagnosis of AML or advanced MDS
• No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C).

Exclusion Criteria:

• Uncontrolled or severe cardiovascular disease or pulmonary disease