Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037583
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2002-05-17
Brief Title:
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid 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 Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin go Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives are a to establish the maximum tolerated dose MTD of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin and b to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin
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