Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, Myelocytic, Acute; Infusions, Intravenous/Ae (Adverse Effects)
Intervention: Mylotarg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: April 2002
Ending date: January 2004
Last updated: May 17, 2006
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