Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
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
- 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
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts
Every month during the first year and every two months during the second year
François-Xavier MAHON, MD
University Hospital Bordeaux, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)