Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
NCT00304447 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2009-07-29
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.
Conditions
- Leukemia, Myelocytic, Acute
- Infusions, Intravenous
Interventions
- DRUG
-
Mylotarg
Sponsors & Collaborators
-
Wyeth is now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-04-30
- Completion
- 2004-01-31
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