Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387647
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2006-10-12
Brief Title:
Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia AML in CR After Induction Chemotherapy
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Multicenter Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy
Status:
COMPLETED
Status Verified Date:
2014-08
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 if patients older than 60 with acute myeloid leukemia who are in complete remission following initial chemotherapy will live longer and have a lower rate of leukemia relapse when treated with azacitidine
Detailed Description:
Patient activity will encompass approximately 48 months an approximate 24 month enrollment period followed by 6 to 12 months of patient treatment Patients will be followed for 1 year following completion of study drug treatment During follow-up bone marrow biopsies to confirm disease status should be obtained if peripheral blood blasts are present or if there is development of unexpected blood abnormalities to warrant suspicion of relapse or at a minimum of every 6 months
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