Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00957385
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2009-08-11
Brief Title:
Maintenance Therapy in Acute Myeloid Leukemia AML Patients
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged 60 Years in CR1 or Higher and 60 Years in CR2 or Higher
Status:
COMPLETED
Status Verified Date:
2009-08
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 determine if Revlimid will help maintain patients with acute myeloid leukemia in remission
Detailed Description:
At present the majority of AML patients 60 years of age that achieve CR and thereafter successfully complete further chemotherapy are not candidates for allogeneic bone marrow transplantation alloBMT due to their age Rather this group of patients is simply observed until relapse occurs In this age group the median duration of CR is only 10 months The survival of patients 60 years of age who are not candidates for transplantation due to donor unavailability and who are in CR2 or higher is also extremely poor Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells
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