Studies how ponatinib levels in blood relate to its effects in chronic myeloid leukemia
Looks at ponatinib blood levels and effects in adults with chronic myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Key facts
- Where
- Cagliari, Milan, Naples, Pisa, and Roma, ItalySee the 5 sites
Where in Italy
- University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow TransplantCagliari, ItalyTaking people
- Policlinico MilanoMilan, ItalyTaking people
- University of Naples Federico II - Unit of HematologyNaples, ItalyTaking people
- Santa Chiara University HospitalPisa, ItalyTaking people
- Ospedale S. Eugenio ASL 2 RomaRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Pisa
- Trial code
- NCT06119269
- Record updated
- 5 June 2025
- Original description
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).Read full original descriptionShow less
Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol
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.
Exclusion: 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; Subjects <18 years old.
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.