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

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Gemtuzumab

Criteria

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.