Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086099
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2004-06-23
Brief Title:
Study Evaluating the Addition of Amifostine Ethyol to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase IBII Randomized Open-Label Multicenter Study Evaluating Whether the Addition of Amifostine Ethyol Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed Previously Untreated Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2009-01
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 primary objectives of this study are
1 To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mgm² in combination with standard-dose ara-C in older patients with newly diagnosed previously untreated acute myeloid leukemia AML and
2 To estimate the complete remission rate of induction therapy with amifostine idarubicin 21 mgm² plus ara-C or induction therapy with idarubicin 12 mgm² plus ara-C in this patient population
1 To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mgm² in combination with standard-dose ara-C in older patients with newly diagnosed previously untreated acute myeloid leukemia AML and
2 To estimate the complete remission rate of induction therapy with amifostine idarubicin 21 mgm² plus ara-C or induction therapy with idarubicin 12 mgm² plus ara-C in this patient population
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