LOW-PV Continuation
ConditionPolycythemia Vera
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 months2
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 months3
Frequency of phlebotomies
Rate of Efficacy
Time frame
From date of randomization until the date of follow up assessed up to 6 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov