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

Phase 4

Completed

• Conditions: Leukemia, Myelocytic, Acute; Infusions, Intravenous

• Registration Number: NCT00304447
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2004-01
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-28
• Last Update Posted: 2009-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.

Secondary Outcome Measures

Name	Time	Method
The effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelets recovery (CRp) at one-month post treatment.