Retrospective-prospective Study to Evaluate Treatment Management and Outcomes of 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.
NCT ID: NCT06441214
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
212 participants
OBSERVATIONAL
2024-12-13
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective cohort
All patients with Waldenström's macroglobulinemia enrolled in Pre-Reimbursement Access Program (PRAP) of Zanubrutinib, as per Compassionate Use Program (CUP) of Zanubrutinib, and patients treated with commercial drug (Brukinsa®) from PRAP closure to the study start.
No interventions assigned to this group
Prospective cohort
Patients with Waldenström's macroglobulinemia treated with Zanubrutinibin clinical practice enrolled from the study start up to 12 months.
Zanubrutinib
Patients will be treated with Zanubrutinib as per routine clinical practice.
Interventions
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Zanubrutinib
Patients will be treated with Zanubrutinib as per routine clinical practice.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Anna Maria Frustaci
Role: PRINCIPAL_INVESTIGATOR
ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
Locations
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A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia
Alessandria, , Italy
A.O.U. Ospedali Riuniti - Clinica di Ematologia
Ancona, , Italy
Ospedale C. e G. Mazzoni - U.O.C. di Ematologia
Ascoli Piceno, , Italy
AOU Policlinico Consorziale - U.O. Ematologia con Trapianto
Bari, , Italy
Nuovo Ospedale degli Infermi - SSD Ematologia
Biella, , Italy
Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
Bologna, , Italy
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
Bolzano, , Italy
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Ematologia
Catania, , Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione
Ferrara, , Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, , Italy
Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia - Ematologia e terapie cellulari
Genova, , Italy
ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan, , Italy
IEO Istituto Europeo di Oncologia - Divisione Ematoncologia
Milan, , Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
Milan, , Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara, , Italy
AOU di Padova - Ematologia
Padua, , Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo, , Italy
RCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia, , Italy
P.O. Spirito Santo di Pescara - UOC Ematologia Dipartimento Oncologico Ematologico - ASL Pescara
Pescara, , Italy
AOU Pisana - U.O. Ematologia
Pisa, , Italy
Ospedale delle Croci - Ematologia
Ravenna, , Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, , Italy
Università Cattolica Sacro Cuore - Ematologia
Roma, , Italy
AOU Senese - U.O.C. Ematologia
Siena, , Italy
Ospedale "G. Mazzini" - UOS Ematologia
Teramo, , 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
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Udine, , Italy
Countries
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Other Identifiers
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FIL_BRUCE-ITA
Identifier Type: -
Identifier Source: org_study_id
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