Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

Recruiting now

Conditions studied: Chronic Myeloid Leukemia, Chronic Phase

In brief

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.

Key facts

Study ID

NCT06119269

Run by

University of Pisa

People needed

100

Starts

2023-08-02

Expected to finish

2025-12-31

Last updated by the study team

2025-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant — Cagliari, Italy (enrolling)
• Policlinico Milano — Milan, Italy (enrolling)
• University of Naples Federico II - Unit of Hematology — Naples, Italy (enrolling)
• Santa Chiara University Hospital — Pisa, Italy (enrolling)
• Ospedale S. Eugenio ASL 2 Roma — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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