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.

NCT06441214 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Italiana Linfomi - ETS

Phase

Observational

Started

2024-12-13

Last updated

2026-08-24

Condition(s) studied

Waldenström's Macroglobulinemia (WM)

Investigational drug(s) / intervention(s)

Zanubrutinib →

Zanubrutinib: Patients will be treated with Zanubrutinib as per routine clinical practice.

Study summary

This is a non-interventional, observational, retrospective and prospective multicenter Italian study, to describe treatment management and outcomes of Waldenström's Macroglobulinemia (WM) patients treated according to the Italian Compassionate Use Program (CUP) and receiving zanubrutinib following its commercial approval.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Cumulative incidence of treatment discontinuation due to toxicity — From the date of first zanubrutinib administration to the date of definitive treatment discontinuation or dose reduction for any cause or death from any cause, from october 2020 up to 24 months since study start
Cumulative incidence of treatment discontinuation due to toxicity

Trial sites (23)

Facility	City	Region
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 Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione	Ferrara	Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia	Florence	Italy
ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia	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	Padova	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
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
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

On this site

📄 Brukinsa (zanubrutinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06441214 on ClinicalTrials.gov ↗ ← All trials in Italy