Real-world Ruxolitinib Experience in PV

Launched by GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called ruxolitinib in adults with a condition known as Polycythemia Vera (PV). This study is specifically looking at patients who have not responded well to another treatment called hydroxyurea or who cannot tolerate it. The trial will include patients who are either already receiving ruxolitinib or will start the treatment during the study. The goal is to observe how effective ruxolitinib is in managing PV over a period of at least three months.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of PV according to specific medical guidelines. They should have a history that shows they have not responded to hydroxyurea or couldn't take it due to side effects. Patients who join the trial will be monitored for their health and response to the treatment. It’s important to know that this study is not yet recruiting participants, and it aims to gather real-world information about the use of ruxolitinib for managing PV.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged ≥ 18 years of age
• • 2. Subjects must be diagnosed with PV according to the 2022 World Health Organization (WHO) or International Consensus Classification (ICC) criteria
• • 3. Subjects must have a treatment history for PV that meets the definition of resistance or intolerance to hydroxyurea (HU) in accordance with the indications of the Italian Medicines Agency
• • 4. Patients already on ruxolitinib treatment (retrospective cohort) at the start date of the study or patients who will start ruxolitinib (prospective cohort) during the study enrollment
• • 5. Signed informed consent
• Exclusion Criteria:
• • 1. Different diagnosis from PV \[eg. other chronic myeloproliferative neoplasia such as essential thrombocythemia, myelofibrosis; or of congenital erythrocytosis or secondary erythrocytosis\]

Trial Officials