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Italian study tracks Real-World use of zanubrutinib for rare blood cancer

NCT ID NCT06441214

Disease control Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 2 times

Summary

This study follows about 212 people in Italy with Waldenström's macroglobulinemia, a rare blood cancer, who are taking the drug zanubrutinib. Researchers are tracking how long patients stay on the drug, side effects, and overall treatment outcomes. The goal is to understand how well the drug works in everyday medical practice, not just in controlled trials.

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

212 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Dec 2026

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

Patients with Waldenström's Macroglobulinemia (WM) treated in Italy according to the Zanubrutinib (Brukinsa®) compassionate use program (CUP) and in common practice following commercial approval.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Signed and dated informed consent form * Waldenström's macroglobulinemia diagnosis in need of treatment according to ESMO (European Society for Medical Oncology) guideline 2018 * Patients who received Zanubrutinib according to the Italian CUP or in common practice following Zanubrutinib commercial approval * Treatment with zanubrutinib according to current SmPC (Summary of Product Characteristics) * Treatment decision before inclusion into this non-interventional study * Age ≥18 years Exclusion Criteria: * Contraindications according to SmPC for patients with WM * Participation in an interventional clinical trial during zanubrutinib treatment * Patients with disease progression during a BTKi treatment (if pre-treated with BTK, only those intolerants are considered eligible)

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Conditions

The condition(s) this trial relates to.

Waldenstrom macroglobulinemia

As listed by the trial registrant

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

Waldenström's macroglobulinemia (WM)

Contacts and locations

Locations

  • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

    Palermo, Italy

  • A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia

    Alessandria, Italy

  • A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria

    Torino, Italy

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

    Torino, Italy

  • A.O.U. Ospedali Riuniti - Clinica di Ematologia

    Ancona, Italy

  • AOU Maggiore della Carità di Novara - SCDU Ematologia

    Novara, Italy

  • AOU Policlinico Consorziale - U.O. Ematologia con Trapianto

    Bari, Italy

  • AOU Senese - U.O.C. Ematologia

    Siena, Italy

  • AOU di Padova - Ematologia

    Padova, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

    Milan, Italy

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione

    Ferrara, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica

    Udine, Italy

  • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

    Reggio Emilia, Italy

  • Nuovo Ospedale degli Infermi - SSD Ematologia

    Biella, Italy

  • Ospedale C. e G. Mazzoni - U.O.C. di Ematologia

    Ascoli Piceno, Italy

  • Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.

    Bolzano, Italy

  • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia

    Milan, Italy

  • Ospedale delle Croci - Ematologia

    Ravenna, Italy

  • P.O. Spirito Santo di Pescara - UOC Ematologia Dipartimento Oncologico Ematologico - ASL Pescara

    Pescara, Italy

  • Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"

    Bologna, Italy

  • RCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

    Pavia, Italy

  • Università Cattolica Sacro Cuore - Ematologia

    Roma, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.