Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia

A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)

The purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events, to evaluate the effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelet recovery (CRp) at one-month post treatment.

Inclusion Criteria:

• Patients with CD33 positive, resistant or relapsed AML.
• Patients > 18 years of age.
• ECOG performance status 0-2.

Exclusion Criteria:

• Fever (>38), chills or hypotension (systolic BP<105mmHg) in the 48 hours preceding therapy.
• Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment.
• Participation in any other Mylotarg® protocol.