NCT05130138 Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia
| NCT ID | NCT05130138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Chronic Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-01-27 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-01-27 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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; Exclusion Criteria: * Legal incapacity or limited capacity ; Medical or psychological incapacity or limited capacity; * Not able to read and/or to write French; * Patient taking Ponatinib.
Contact & Investigator
Xavier SIMOENS, MD, PhD
PRINCIPAL INVESTIGATOR
CHU de Saint-Etienne
Frequently Asked Questions
Who can join the NCT05130138 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05130138 currently recruiting?
Yes, NCT05130138 is actively recruiting participants. Contact the research team at elisabeth.daguenet@chu-st-etienne.fr for enrollment information.
Where is the NCT05130138 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT05130138 clinical trial?
NCT05130138 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Xavier SIMOENS, MD, PhD at CHU de Saint-Etienne. The trial plans to enroll 100 participants.
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