LOW-PV Continuation

Active, not recruiting

• Conditions: Polycythemia Vera

• Registration Number: NCT06752941
• Lead Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

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.

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 Timeline

• Study Start: 2024-11-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-11-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complete hematological (CHR) and clinical remission (CR)	From date of randomization until the date of follow up assessed up to 6 months	Rate of Efficacy
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	Rate of Efficacy
Frequency of phlebotomies	From date of randomization until the date of follow up assessed up to 6 months	Rate of Efficacy
Change in spleen size since treatment start	From date of randomization until the date of follow up assessed up to 6 months	Rate of Efficacy
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.	Rate of Efficacy
Discontinuation of Ropeginterferon alfa-2b for any reason	From date of randomization until the date of follow up assessed up to 6 months	Rate of Efficacy
Incidence and grading of any adverse event related to Ropeginterferon alfa-2b	From date of randomization until the date of follow up assessed up to 6 months	Rate of Safety

Trial Locations

Locations (13)

Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia; 🇮🇹 Pavia, Lombardia, Italy

Ospedale Borgo Roma, Divisione Ematologia; 🇮🇹 Verona, Veneto, Italy

ASST Papa Giovanni XXIII, SC Ematologia; 🇮🇹 Bergamo, Italy

Policlinico S. Orsola - Malpighi, UO Ematologia; 🇮🇹 Bologna, Italy

Azienda Ospedaliero Universitaria Careggi, SOD Ematologia; 🇮🇹 Firenze, Italy

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia; 🇮🇹 Milano, Italy

Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo; 🇮🇹 Milano, Italy

Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo; 🇮🇹 Napoli, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia; 🇮🇹 Novara, Italy

Policlinico Universitario Fondazione Agostino Gemelli; 🇮🇹 Roma, Italy

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U; 🇮🇹 Torino, Italy

ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia; 🇮🇹 Varese, Italy

Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia; 🇮🇹 Vicenza, Italy