Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478985
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2007-05-23
Brief Title:
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia STIM
Status:
COMPLETED
Status Verified Date:
2013-07
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:
STIM
Brief Summary:
The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment determine by Reverse Transcription real-time Polymerase Chain Reaction RT-PCR negative for bcr-abl transcripts The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission
Detailed Description:
Principal Objective To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia
Secondary Objective
To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia
To determine the biologics factors immunologic and molecular associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia
To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib
To determine the complete molecular remission length
To evaluate medical and economical impact of stopping imatinib treatment
Study design multicentric trial
Secondary Objective
To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia
To determine the biologics factors immunologic and molecular associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia
To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib
To determine the complete molecular remission length
To evaluate medical and economical impact of stopping imatinib treatment
Study design multicentric trial
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