Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol
University of Pisa
100 participants
Aug 2, 2023
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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 Criteria3
- 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.
Interventions
At each follow up visit, plasma concentrations of ponatinib will be measured and compared with therapeutic range (according to a lower concentration equal to 21 nM)
BCR-ABl transcript levels will be assessed to evaluate molecular response to ponatinib
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06119269