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This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.
Full description
Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost during the study or if the subject withdraw the informed consenting.
The primary objective is to measure the number of subject that sustain the major molecular response (RM3log or BCR-ABL level below 0.1%) after 2 years of follow-up.
BCR: breakpoint cluster region
ABL: abelson murine leukemia
RM3log: major molecular response, BCR-ABL level below 0.1% (IS)
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Inclusion criteria
Exclusion criteria
IS: International Scale
MR4log: molecular response of 4log or <0,1% (IS)
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Interventional model
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30 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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