Real-world Ruxolitinib Experience in PV (REVIEW)

May 8, 2024 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Real-world Ruxolitinib Experience in Polycythemia Vera: REVIEW Study

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of Polycythemia vera according to WHO or ICC 2022 criteria who received treatment with ruxolitinib as second-line therapy for resistance / intolerance to hydroxyurea, according to the prescription criteria approved in Italy. Patients already on treatment (retrospective part) at the start date of the study and patients included after the start date for a period of 9 months may be included in the study

Description

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]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Paola Guglielmelli, AOU Careggi, University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPN0224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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