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

Study acronym: PHARM-LMC
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 1 month later Nov 1, 2025 → Dec 31, 2027
See other at-risk trials from Centre Hospitalier Universitaire de Saint Etienne

Record History

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  1. Primary completion pushed from Nov 1, 2025 to Dec 31, 2027
    • Study completion pushed from Nov 1, 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Primary completion date: Nov 1, 2024 to Nov 1, 2025
    • Study completion date: Nov 1, 2025 to Nov 1, 2026
    v6
  3. Primary completion date: Nov 1, 2023 to Nov 1, 2024
    • Study completion date: Nov 1, 2024 to Nov 1, 2025
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 10, 2022 to Jan 27, 2022
    • Site details revised
    v3
  6. Lead sponsor: Institut de Cancérologie de la Loire to Centre Hospitalier Universitaire de Saint Etienne
    • Start date: Dec 1, 2021 to Feb 10, 2022
    • Study site revised
    • Collaborator revised
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT05130138
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Institut de Cancérologie de la Loire
Conditions
(from sponsor)		 Chronic Myeloid Leukemia
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov