Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Apr 26, 2011

Keywords

ClinConnect Summary

The gold standard for the treatment of chronic myeloid leukaemia (CML) is Imatinib, the first tyrosine inhibitor (TKI) of BCR-ABL. Imatinib specifically targets the BCR-ABL tyrosine kinase encoded by the BCR-ABL fusion gene, the molecular hallmark of CML. Regular monitoring of BCR-ABL transcript levels by quantitative RT-PCR is of key importance for the assessment of treatment response to imatinib.

Over time, an increasing proportion of imatinib-treated patients obtain a complete molecular response (CMR), defined as an undetectable molecular residual disease. In a previous study, STIM tria...

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Eligibility criteria

• Inclusion Criteria:
• • 18 years and older.
• • Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years.
• • Complete molecular remission under treatment with imatinib for at least 2 years.
• • HIV serology negative and absence of chronic hepatitis B or C.
• • Molecular monitoring according to the international recommendations before the beginning of the study
• • For the women old enough to procreate, method of effective contraception
• • All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
• Exclusion Criteria:
• • Under 18 years old.
• • Pregnant at the inclusion's time.
• • Hospitalized patients without consent.
• • Adults under law protection or without ability to assent.
• • Previous or planned allogeneic stem cell transplantation.
• • HIV serology positive or chronic hepatitis B or C.
• • Interfering treatment (corticosteroids, immunosuppressors, chemotherapy, radiotherapy).