Status:
RECRUITING
Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Lead Sponsor:
University of Pisa
Conditions:
Chronic Myeloid Leukemia, Chronic Phase
Eligibility:
All Genders
18+ years
Brief 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 affec...
Detailed Description
The study protocol is a non-interventional, retrospective observational study which involves the collection of data from medical records relating to the plasma dosages of ponatinib performed as per cl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06119269
Start Date
August 2 2023
End Date
December 31 2025
Last Update
June 5 2025
Active Locations (5)
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1
University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant
Cagliari, Italy, 09124
2
Policlinico Milano
Milan, Italy, 20122
3
University of Naples Federico II - Unit of Hematology
Napoli, Italy, 80131
4
Santa Chiara University Hospital
Pisa, Italy, 56126