Trial Information
A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
0903X-100863
NCT ID:
NCT00304447
Start Date:
April 2002
Completion Date:
January 2004
Related Keywords:
- Leukemia, Myelocytic, Acute
- Infusions, Intravenous
- Leukemia
- Mylotarg
- Safety
- Adverse Events
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid