Study of Ponatinib Plasma Levels and Effects in Adults with Chronic Myeloid Leukemia in Chronic Phase

What this Trial Is About

Researchers are evaluating the relationship between the blood levels of ponatinib and its effects, including both how well it works and its side effects, in patients with chronic myeloid leukemia in the chronic phase CML-CP. This retrospective observational study aims to understand these associations in patients treated at multiple Italian hematological centers. It also seeks to develop an algorithm to help doctors adjust ponatinib doses based on plasma concentrations, tolerability, and molecular response to treatment. The study involves collecting data from medical records of CML-CP patients who have been treated with ponatinib as a second, third, or fourth line of chemotherapy. Plasma levels of ponatinib measured during routine clinical practice will be analyzed alongside efficacy data, such as molecular response, and records of side effects. Researchers will use statistical and pharmacokinetic modeling to explore factors influencing ponatinib levels and to build a dosing algorithm. Participants clinical and laboratory data will be anonymized and gathered into a database for analysis. The study will review ponatinib plasma concentrations over two years, along with molecular response and occurrence of adverse events during this period. This approach aims to provide insights from real-life treatment experiences, supporting improved dosing decisions in the future.

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase