NCT06119269Recruiting
Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol
Source: ClinicalTrials.gov · Last updated 5 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 18 Oct 2023
- Start date
- 2 Aug 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Pisa
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT06119269
What you commit to
- Study type: Observational
- Planned participants: 100
- From 2 Aug 2023 to the primary completion date, 31 Dec 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Age
- Subjects \<18 years old
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Policlinico Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| University of Naples Federico II - Unit of Hematology Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Santa Chiara University Hospital Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Ospedale S. Eugenio ASL 2 Roma Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.