Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304447
Status:
COMPLETED
Last Update Posted:
2009-07-29
First Post:
2006-03-15
Brief Title:
Study Evaluating the Effect of Corticosteroids on Mylotarg Infusion-Related Adverse Events in Patients With Leukemia
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg in Patients With Acute Myelogenous Leukemia AML
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 efficacy of Mylotarg induced complete response CR and complete response with incomplete platelet recovery CRp at one-month post treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None