Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pisa
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Subjects <18 years old
Patients who did not provide an informed consent to the study
Trial design
Treatments tested in this trial
- Therapeutic drug monitoring
- Molecular Response
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov