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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites30 target enrollmentApril 2002

ConditionsLeukemia, Myelocytic, Acute Infusions, Intravenous

DrugsMylotarg

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Leukemia, Myelocytic, Acute
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 30
Primary Endpoint: The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2002

End Date

January 2004

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.