Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Pharmaceutical intervention

    Other intervention

    Patients with pharmacokinetic and/or pharmacodynamics interactions will be proposed to participate to educational sessions to discuss about treatments taken and modifications possibilities.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Pharmaceutical conciliationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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).

Time frame
12 months
2

Concomitant treatments

Concomitant treatments will be reported during 12 months.

Time frame
12 months
3

Tyrosine kinase inhibitor observance

Observance to Tyrosine kinase inhibitor will be measured with Girerd Questionnaire.

Time frame
12 months
4

Side effects

Number and description of sides effects will be reported.

Time frame
12 months

Other outcomes

Sponsors and contacts

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Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Institut de Cancérologie de la Loire

Collaborator