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New drug for rare blood cancer studied in everyday practice

NCT ID NCT06506084

Disease control Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study looks at how well the drug ropeginterferon alfa-2b works and is tolerated by people with polycythemia vera, a rare blood disorder that raises the risk of blood clots and can turn into more serious disease. About 319 adults who need this treatment will be followed for up to two years in real-world clinics. The goal is to see if the drug helps control blood counts and improves daily life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 429 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The first time point to assess the primary outcome defined as the achievement of CHR is after 12 months of treatment with ropeginterferon alfa-2b, is reasonable to provide evidence of at least a non-inferiority in terms of CHR with this new drug. In this framework, a sample size is calculated to test 1-sample non-inferiority of a proportion. Setting the expected proportion p of CHR under ropeginterferon alfa-2b equals to the reference value (p0) obtained with ruxolitinib (i.e., p = p0 = 0.24), a sample size of 319 is needed to demonstrate that the proportion of CHR under ropeginterferon alfa-2b is not inferior to that obtained under ruxolitinib, allowing a margin of non-inferiority (delta) of 0.07 and assuming alpha and beta errors of 5% and 10%, respectively.

Ages

18 to 100 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with Polycythemia Vera by WHO 2016 * Patient aged ≥ 18 years old * Patients in need of cytoreductive treatments with ropeginterferon alfa-2b in first or later lines according to the reimbursability criteria defined by the Italian National Health System * Patients who have signed the written informed consent for study participation. Exclusion Criteria: • Any contraindication for ropeginterferon alfa-2b according to the SmPC

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polycythemia vera

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U

    RECRUITING

    Torino, 10126, Italy

  • A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria

    RECRUITING

    Alessandria, 15121, Italy

  • ASST MONZA Ospedale San Gerardo Clinica Ematologica

    RECRUITING

    Monza, 20900, Italy

  • ASST-Spedali Civili

    RECRUITING

    Brescia, 25123, Italy

  • Arcispedale Sant'Anna Azienda Ospedaliero - Universitaria di Ferrara, Unità Operativa di Ematologia

    RECRUITING

    Ferrara, Italy

  • Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,

    RECRUITING

    Cuneo, 2100, Italy

  • Azienda Ospedaliera San Eugenio - UOC Ematologia

    RECRUITING

    Roma, Italy

  • Azienda Ospedaliera Universitaria Careggi, Divisione di Ematologia

    RECRUITING

    Florence, Italy

  • Azienda Ospedaliera Universitaria Consorziale - Policlinico, U.O. Ematologia con Trapianto

    RECRUITING

    Bari, Italy

  • Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Pisana

    RECRUITING

    Pisa, Italy

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino", UOC Ematologia

    RECRUITING

    Messina, Italy

  • Azienda Ospedaliera Universitaria Policlinico "P. Giaccone", Divisione di Ematologia

    RECRUITING

    Palermo, Italy

  • Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di Ematologia con Trapianto di midollo Osseo

    RECRUITING

    Catania, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

    RECRUITING

    Novara, 28100, Italy

  • Azienda Sanitaria Universitaria Integrata, Presidio Ospedaliero "Santa Maria della Misericordia", Clinica Ematologica

    RECRUITING

    Udine, Italy

  • Clinica Medica I Azienda Ospedaliera di Padova

    RECRUITING

    Padova, Veneto, 35128, Italy

  • Copernicus Hospital

    RECRUITING

    Lodz, Poland

  • Divisione Ematologia ASST, Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Lombardy, 20162, Italy

  • Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • Divisione Ematologia, Ospedale Borgo Roma

    RECRUITING

    Verona, Veneto, 37134, Italy

  • Divisione Ematologia, Ospedale San Bortolo

    RECRUITING

    Vicenza, Veneto, Italy

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia

    RECRUITING

    Milan, Italy

  • Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC Ematologia

    RECRUITING

    Roma, Italy

  • Jagiellonian University Hospital, Department of Haematology

    RECRUITING

    Krakow, Poland

  • Medical University, Clinical Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation

    RECRUITING

    Wroclaw, Poland

  • Ospedale Businco, S.C. Ematologia e CTMO

    RECRUITING

    Cagliari, Italy

  • Ospedale Casa Sollievo della Sofferenza Istituto di Ricovero e Cura a Carattere Scientifico, U.O. Ematologia

    RECRUITING

    San Giovanni Rotondo, Italy

  • Ospedale Maggiore, SC Ematologia

    RECRUITING

    Trieste, Italy

  • Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo

    RECRUITING

    Milan, Italy

  • Ospedale dell'Angelo, Dipartimento di Ematologia

    RECRUITING

    Mestre, Italy

  • Policlinico S. Orsola - Malpighi, Unità di Ematologia

    RECRUITING

    Bologna, Italy

  • Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia

    RECRUITING

    Roma, Italy

  • Pratia Onkologia, Department of Hematology and Cancer Prevention

    RECRUITING

    Katowice, Poland

  • SC Ematologia, ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, Lombardy, 24127, Italy

  • U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese

    RECRUITING

    Varese, Lombardy, 21100, Italy

  • University Medical Center, Department of Hematology and Transplantation

    RECRUITING

    Gdansk, Poland

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