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.
Study Type
OBSERVATIONAL
Enrollment
36
Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia
Pavia, Lombardy, Italy
NOT_YET_RECRUITINGOspedale Borgo Roma, Divisione Ematologia
Verona, Veneto, Italy
Maintenance of Treatment response
Median HCT lower than 45% without disease progression
Time frame: From date of randomization until the date of follow up assessed up to 6 months.
Complete hematological (CHR) and clinical remission (CR)
Rate of Efficacy
Time frame: 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
Rate of Efficacy
Time frame: From date of randomization until the date of follow up assessed up to 6 months
Frequency of phlebotomies
Rate of Efficacy
Time frame: 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
Time frame: 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
Time frame: During the follow up every 6months per patient.
Discontinuation of Ropeginterferon alfa-2b for any reason
Rate of Efficacy
Time frame: From date of randomization until the date of follow up assessed up to 6 months
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ASST Papa Giovanni XXIII, SC Ematologia
Bergamo, Italy
RECRUITINGPoliclinico S. Orsola - Malpighi, UO Ematologia
Bologna, Italy
RECRUITINGAzienda Ospedaliero Universitaria Careggi, SOD Ematologia
Florence, Italy
RECRUITINGFondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia
Milan, Italy
RECRUITINGOspedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
Milan, Italy
RECRUITINGAzienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Naples, Italy
RECRUITINGAzienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
Novara, Italy
RECRUITINGPoliclinico Universitario Fondazione Agostino Gemelli
Roma, Italy
NOT_YET_RECRUITING...and 3 more locations
Incidence and grading of any adverse event related to Ropeginterferon alfa-2b
Rate of Safety
Time frame: From date of randomization until the date of follow up assessed up to 6 months