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Completed

NCT Number: NCT06752941

LOW-PV Continuation

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.

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Key information

Conditions

Polycythemia Vera Bone Marrow Diseases Bone Marrow Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Site

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia, Pavia, Lombardy, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Maintenance of Treatment response

    Time frame: From date of randomization until the date of follow up assessed up to 6 months.

    Median HCT lower than 45% without disease progression

Secondary outcomes

  1. Complete hematological (CHR) and clinical remission (CR)

    Time frame: From date of randomization until the date of follow up assessed up to 6 months

    Rate of Efficacy

  2. Change in JAK2 variant allele frequency (VAF) since treatment start

    Time frame: From date of randomization until the date of follow up assessed up to 6 months

    Rate of Efficacy

  3. Frequency of phlebotomies

    Time frame: From date of randomization until the date of follow up assessed up to 6 months

    Rate of Efficacy

  4. Change in spleen size since treatment start

    Time frame: From date of randomization until the date of follow up assessed up to 6 months

    Rate of Efficacy

  5. 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

    Time frame: During the follow up every 6months per patient.

    Rate of Efficacy

  6. Discontinuation of Ropeginterferon alfa-2b for any reason

    Time frame: From date of randomization until the date of follow up assessed up to 6 months

    Rate of Efficacy

  7. Incidence and grading of any adverse event related to Ropeginterferon alfa-2b

    Time frame: From date of randomization until the date of follow up assessed up to 6 months

    Rate of Safety

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Acronym: CONT-LOW-PV

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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