A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
- Patients with CD33 positive, resistant or relapsed AML.
- Patients > 18 years of age.
- ECOG performance status 0-2.
- Fever (>38), chills or hypotension (systolic BP<105mmHg) in the 48 hours preceding
- Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of
- Participation in any other Mylotarg® protocol.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
Wyeth is now a wholly owned subsidiary of Pfizer
United States: Food and Drug Administration
- Leukemia, Myelocytic, Acute
- Infusions, Intravenous
- Adverse Events
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid