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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete hematological (CHR) and clinical remission (CR) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| TIZIANO BARBUI, MD | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia | Pavia | Lombardy | 27100 | Italy | ||
| Ospedale Borgo Roma, Divisione Ematologia |
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| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Rate of Efficacy
| From date of randomization until the date of follow up assessed up to 6 months |
| Frequency of phlebotomies | 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 | 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 | Rate of Efficacy | During the follow up every 6months per patient. |
| Discontinuation of Ropeginterferon alfa-2b for any reason | 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 | Rate of Safety | From date of randomization until the date of follow up assessed up to 6 months |
| Verona |
| Veneto |
| 37134 |
| Italy |
| ASST Papa Giovanni XXIII, SC Ematologia | Bergamo | Italy |
| Policlinico S. Orsola - Malpighi, UO Ematologia | Bologna | Italy |
| Azienda Ospedaliero Universitaria Careggi, SOD Ematologia | Florence | Italy |
| Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia | Milan | Italy |
| Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo | Milan | Italy |
| Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia | Novara | 28100 | Italy |
| Policlinico Universitario Fondazione Agostino Gemelli | Roma | 00168 | Italy |
| A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U | Torino | 10126 | 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 |
| D001855 |
| Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |