Real-world Ruxolitinib Experience in PV

Real-world Ruxolitinib Experience in Polycythemia Vera: REVIEW Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06251102

Acronym

REVIEW

Enrollment

153

Registered

2024-02-09

Start date

2024-07-31

Completion date

2025-07-31

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera

Keywords

ruxolitinib

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 \[eg. other chronic myeloproliferative neoplasia such as essential thrombocythemia, myelofibrosis; or of congenital erythrocytosis or secondary erythrocytosis\]

Design outcomes

Primary

Measure	Time frame	Description
effectiveness of ruxolitinib	at 3 months	Proportion of patients who reach the target hct \<45% within 3 months in the absence of phlebotomy

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it0670390528

Backup ContactEnrico Crea

e.crea@gimema.it0670390514

Outcome results