LOW-PV Continuation (CONT-LOW-PV)

December 19, 2025 updated by: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
This multicenter longitudinal observational study focuses on Italian patients with Polycythemia Vera (PV) who were enrolled in the Low-PV RCT and continued receiving Ropeginterferon alfa-2b until the study's conclusion on March 31, 2023. It includes patients who were responders to Ropeginterferon alfa-2b after two years in the phase II randomized trial "LOW-PV." Data will be collected retrospectively every 6 months from March 31, 2023 to November 30, 2024 and prospectively from December 1, 2024 to March 31, 2026.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Multicentre longitudinal observational Italian study of patients with Polycythemia Vera (PV) enrolled in Low-PV RCT and still receiving the experimental drug (i.e., Ropeginterferon alfa-2b) at study end (31-03-2023). Thirty-six patients who completed the Low-PV RCT and were responders to Interferon, continued treatment with the drug and are followed at their respective centers in Italy. The "LOW-PV Continuation" study aims to collect after 1,2,3 years the data on these patients, regardless of the treatment they were undergoing at the time of enrollment in the current study, after their informed consent. In details, data will be collected retrospectively from March 31, 2023 to November 2024 and prospectively from December 1, 2024 to March 31, 2026.

Given the descriptive nature of the study, no formal statistical hypothesis will be made.

Study Type

Observational

Enrollment (Estimated)

36

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

Study Locations

  • Italy
      • Bergamo, Italy
        • Recruiting
        • ASST Papa Giovanni XXIII, SC Ematologia
        • Contact:
        • Sub-Investigator:
          • Marta Bellini, MD
        • Principal Investigator:
          • Alessandro Rambaldi, MD
        • Sub-Investigator:
          • Maria Chiara Finazzi, MD
        • Sub-Investigator:
          • Annalisa Condorelli, MD
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola - Malpighi, UO Ematologia
        • Contact:
        • Principal Investigator:
          • Michele Cavo, MD
        • Sub-Investigator:
          • Francesca Palandri, MD
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi, SOD Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandro Maria Vannucchi, MD
        • Sub-Investigator:
          • Francesca Guglielmelli, MD
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandra Iurlo, MD
      • Milan, Italy
        • Recruiting
        • Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
        • Contact:
        • Principal Investigator:
          • Francesca Lunghi, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
        • Principal Investigator:
          • Fabrizio Pane, MD
        • Contact:
        • Sub-Investigator:
          • Novella Pugliese, MD
        • Sub-Investigator:
          • GIada Miccioli Casadei, MD
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
        • Contact:
        • Principal Investigator:
          • Andrea Patriarca, MD
      • Roma, Italy, 00168
      • Torino, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
        • Contact:
        • Principal Investigator:
          • Giulia Benevolo, MD
      • Varese, Italy
        • Recruiting
        • ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia
        • Principal Investigator:
          • Marco Brociner, MD
        • Contact:
      • Vicenza, Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia
        • Contact:
        • Principal Investigator:
          • ELisa Rumi, MD
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Not yet recruiting
        • Ospedale Borgo Roma, Divisione Ematologia
        • Principal Investigator:
          • Massimiliano Bonifacio, MD
        • Contact:
        • Sub-Investigator:
          • Luigi Scaffidi, MD

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

No

Sampling Method

Probability Sample

Study Population

Thirty-six patients completed the Low-PV RCT and were still under treatment with Ropeg at study end. The "LOW-PV Continuation" study aim to update data of all these patients, regardless of the treatment they are undergoing at the time of enrollment in the current study, after having obtained their informed consent to participation.

Description

Inclusion Criteria:

  • Patients enrolled in the LOW-PV RCT study who continued to receive Ropeginterferon alfa-2b until the conclusion of the study on March 31, 2023. These patients will be included regardless of the treatment they are undergoing at the time of enrollment in the current study.
  • Patients who have signed the written informed consent for study participation.

Exclusion Criteria:

  • None

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
Maintenance of Treatment response
Time Frame: From date of randomization until the date of follow up assessed up to 6 months.
Median HCT lower than 45% without disease progression
From date of randomization until the date of follow up assessed up to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete hematological (CHR) and clinical remission (CR)
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Change in JAK2 variant allele frequency (VAF) since treatment start
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Frequency of phlebotomies
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Change in spleen size since treatment start
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Incidence of any of the following: o arterial and venous thrombotic events; o hemorrhagic events; o disease related symptoms; o disease evolutions into myelofibrosis and acute leukemia; o secondary malignancies o death
Time Frame: During the follow up every 6months per patient.
Rate of Efficacy
During the follow up every 6months per patient.
Discontinuation of Ropeginterferon alfa-2b for any reason
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Incidence and grading of any adverse event related to Ropeginterferon alfa-2b
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Safety
From date of randomization until the date of follow up assessed up to 6 months

Collaborators and Investigators

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

Sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Investigators

  • Study Director: TIZIANO BARBUI, MD, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

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 (Actual)

November 30, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOW-PV Continuation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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