Clinical trial NCT06752941: LOW-PV Continuation
Official title: LOW-PV Continuation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Polycythemia Vera
Keywords: Ropeginterferon alfa-2b
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maintenance of Treatment response
timeFrame: From date of randomization until the date of follow up assessed up to 6 months.
Secondary outcomes:
measure: Complete hematological (CHR) and clinical remission (CR)
timeFrame: From date of randomization until the date of follow up assessed up to 6 months
measure: Change in JAK2 variant allele frequency (VAF) since treatment start
timeFrame: From date of randomization until the date of follow up assessed up to 6 months
measure: Frequency of phlebotomies
timeFrame: From date of randomization until the date of follow up assessed up to 6 months
measure: Change in spleen size since treatment start
timeFrame: From date of randomization until the date of follow up assessed up to 6 months
measure: 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
timeFrame: During the follow up every 6months per patient.
measure: Discontinuation of Ropeginterferon alfa-2b for any reason
timeFrame: From date of randomization until the date of follow up assessed up to 6 months
measure: Incidence and grading of any adverse event related to Ropeginterferon alfa-2b
timeFrame: From date of randomization until the date of follow up assessed up to 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia
state: Lombardia
city: Verona
country: Italy
facility: Ospedale Borgo Roma, Divisione Ematologia
state: Veneto
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII, SC Ematologia
city: Bologna
country: Italy
facility: Policlinico S. Orsola - Malpighi, UO Ematologia
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi, SOD Ematologia
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia
city: Milano
country: Italy
facility: Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
city: Roma
country: Italy
facility: Policlinico Universitario Fondazione Agostino Gemelli
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
city: Varese
country: Italy
facility: ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia
city: Vicenza
country: Italy
facility: Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia
Study officials:
affiliation: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
name: TIZIANO BARBUI, MD
role: STUDY_DIRECTOR
References: