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Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

Recruitingn/aAges 18 Years - anyAllUniversity of Pisa
NCT06119269 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy/tolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP). In particular, the aims of the study will be: * primary aim: to investigate the relationships (if any) between plasma concentrations and activity/toxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers; * secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy). The study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.

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📋 Eligibility rules (as published)
Patients will be enrolled according the following inclusion criteria: * Subjects ≥18 years old affected by CML * Patients being treated with ponatinib at a dose of 45, 30 or 15 mg/day for more than 14 days * Patients who have provided informed consent to the study Exclusion criteria: * Subjects \<18 years old * Patients who did not provide an informed consent to the study The co-administration of drugs other than ponatinib will not be considered an exclusion criterium, but all of the drugs will be registered (together with daily doses and duration of treatment) as possible factors of ponatinib PK variability.
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What it tests

  • Therapeutic drug monitoring
  • Molecular Response
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Where

5 sites
University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant
Cagliari, Italy
Policlinico Milano
Milan, Italy
University of Naples Federico II - Unit of Hematology
Naples, Italy
Santa Chiara University Hospital
Pisa, Italy
Ospedale S. Eugenio ASL 2 Roma
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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