LOW-PV Continuation

NCT06752941 | Recruiting

• 1 other identifier: LOW-PV Continuation
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Polycythemia Vera

Keywords

Ropeginterferon alfa-2b

Outcome Measures

Primary Outcomes (1)

• Maintenance of Treatment response

  Median HCT lower than 45% without disease progression

  From date of randomization until the date of follow up assessed up to 6 months.

Secondary Outcomes (7)

• Complete hematological (CHR) and clinical remission (CR)

  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

  From date of randomization until the date of follow up assessed up to 6 months

• Frequency of phlebotomies

  From date of randomization until the date of follow up assessed up to 6 months

• Change in spleen size since treatment start

  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

  During the follow up every 6months per patient.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (13)

Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia

Pavia, Lombardy, 27100, Italy

NOT YET RECRUITING

Ospedale Borgo Roma, Divisione Ematologia

Verona, Veneto, 37134, Italy

NOT YET RECRUITING

ASST Papa Giovanni XXIII, SC Ematologia

Bergamo, Italy

RECRUITING

Policlinico S. Orsola - Malpighi, UO Ematologia

Bologna, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi, SOD Ematologia

Florence, Italy

RECRUITING

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia

Milan, Italy

RECRUITING

Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo

Milan, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

Naples, 80131, Italy

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

Novara, 28100, Italy

RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Roma, 00168, Italy

NOT YET RECRUITING

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U

Torino, 10126, Italy

RECRUITING

ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia

Varese, Italy

RECRUITING

Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia

Vicenza, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Polycythemia Vera

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Study Officials

• TIZIANO BARBUI, MD

  FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

  STUDY DIRECTOR

Central Study Contacts

TIZIANO BARBUI, MD

CONTACT

+39 0352675134; tbarbui@fondazionefrom.it

FRANCESCA FENILI

CONTACT

sperimentazioni@fondazionefrom.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 31, 2024
• Study Start: November 30, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)