Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
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|ClinicalTrials.gov Identifier: NCT00478985|
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : July 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Myeloid Leukemia, Chronic||Behavioral: Imatinib ending||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Imatinib treatment ending
Behavioral: Imatinib ending
Interruption of the treatment by Imatinib
- Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts [ Time Frame: Every month during the first year and every two months during the second year ]
- T lymphocytes differenciation and proliferation analyse / cytokines production analyse [ Time Frame: first visit, M2,M4,M6,M9,M12,M18,M24 ]
- T lymphocytes apoptosis analyse [ Time Frame: first visit ]
- Haemogramme analyse [ Time Frame: every months during two years ]
- Clinical exam [ Time Frame: every three months during the first year and every four months during the second year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478985
|Principal Investigator:||François-Xavier MAHON, MD||University Hospital Bordeaux, France|