Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

Launched by UNIVERSITY OF PISA · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how the drug ponatinib works in patients with chronic myeloid leukemia (CML) who are in the chronic phase of the disease. Researchers want to understand the relationship between the levels of ponatinib in the blood and how well it works or causes side effects in patients. The study will also develop a tool to help doctors adjust the dose of ponatinib based on individual patient information, like blood drug levels and how well the patient is responding to treatment.

To participate in this study, patients need to be at least 18 years old and currently treated with ponatinib for their CML at specific doses. They must also agree to take part in the study. Participants can expect to provide information about their treatment and health, which will help researchers learn more about the best ways to use ponatinib. If you're considering joining, it's important to know that other medications you might be taking won't disqualify you, but they'll be noted in the study to see how they might affect the way ponatinib works.

Gender

ALL

Eligibility criteria

• 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.