Status:
COMPLETED
Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Leukemia, Myelocytic, Acute
Infusions, Intravenous
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 effi...
Eligibility Criteria
Inclusion
- Patients with CD33 positive, resistant or relapsed AML.
- Patients \> 18 years of age.
- ECOG performance status 0-2.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00304447
Start Date
April 1 2002
End Date
January 1 2004
Last Update
July 29 2009
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