drugset / Trial / NCT00304447

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

NCT00304447

Phase 4 Completed 30 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2002-04
Primary completion
Completion
2004-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody