Polycythemia Vera
Conditions
Keywords
Ropeginterferon alfa-2b
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.
Interventions
None listed
Sponsors
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
STUDY_DIRECTORTIZIANO BARBUI, MD
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Outcome results
None listed