Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
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|ClinicalTrials.gov Identifier: NCT00304447|
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : July 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myelocytic, Acute Infusions, Intravenous||Drug: Mylotarg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2002|
|Study Completion Date :||January 2004|
- The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304447
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|