Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195000
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2005-09-13
Brief Title:
Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2013-06
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 find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years
Detailed Description:
To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years
Patients eligible for treatment will receive the following
Mylotarg at 6 mgm2 on day 1 as a 2 hour intravenous infusion
Cytarabine at 100 mgm2day as a continuous intravenous infusion daily for 7 days
Patients eligible for treatment will receive the following
Mylotarg at 6 mgm2 on day 1 as a 2 hour intravenous infusion
Cytarabine at 100 mgm2day as a continuous intravenous infusion daily for 7 days
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