Myeloid Leukemia, Chronic Clinical Trial
Official title:
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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