Real-world Ruxolitinib Experience in PV (REVIEW)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Not yet enrolling

Conditions: Polycythemia Vera

Study type: Observational

Funder types: Other

Identifiers

NCT06251102

MPN0224

Details and patient eligibility

About

This is a multicentric, observational, retro-prospective study in adult PV patients - resistant or intolerant to hydroxyurea - who are going to receive or have already initiated treatment with ruxolitinib according to the approved local label. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

Full description

This is a multicentric, observational, retro-prospective study in adult population who have been diagnosed with polycythemia vera according to the 2022 (WHO or ICC) criteria, who are resistant or intolerant to hydroxyurea and who are going to be prescribed or have already initiated treatment with ruxolitinib according to the approved local label. Patients who started treatment with ruxolitinib - according to clinical practice - will be enrolled. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

Enrollment: 153 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]