About this trial
The aim of this trial is therefore to identify concomitant treatments with taking Tyrosine Kinase Inhibitor (=TKI) in the indication of Chronic Myeloid Leukemia (CML), whatever the stage of the disease, via pharmaceutical conciliation. These concomitant treatments as well as their dosages will be correlated with the TKI dosage since patients must have a sufficient residual concentration to be considered effective and to confirm adherence to treatment, the leading cause of treatment failure.
In the event of unsatisfactory results, pharmaceutical interventions may take place: changes in treatments (TKI and not TKI) and / or dosages. In case of modification, a new dosage of TKI should be carried out.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Major patient;
Patient affiliated to a social security scheme;
Patient suffering from Chronic Myeloid Leukemia, taking a Tyrosine Kinase Inhibitor (Imatinib, Nilotinib, Dasatinib, or Bosutinib);
Molecular response < 4,5 Log;
Disqualifiers
Legal incapacity or limited capacity ; Medical or psychological incapacity or limited capacity;
Not able to read and/or to write French;
Patient taking Ponatinib.
Trial design
Single group
Treatments tested in this trial
Pharmaceutical intervention
Other interventionPatients with pharmacokinetic and/or pharmacodynamics interactions will be proposed to participate to educational sessions to discuss about treatments taken and modifications possibilities.
Treatment groups
Trial outcomes
Primary outcomes
Number of patients for whom pharmaceutical interventions have been done
Number of patients for whom pharmaceutical interventions have been done secondly to pharmaceutical conciliation will be reported.
Secondary outcomes
Molecular response
Molecular response will be reported via BCR-ABL transcript rate measured by quantitative polymerase chain reaction (qPCR) or digital polymerase chain reaction (PCR).
Concomitant treatments
Concomitant treatments will be reported during 12 months.
Tyrosine kinase inhibitor observance
Observance to Tyrosine kinase inhibitor will be measured with Girerd Questionnaire.
Side effects
Number and description of sides effects will be reported.
Sponsors and contacts
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Centre Hospitalier Universitaire de Saint Etienne
Lead sponsor
Institut de Cancérologie de la Loire
Collaborator