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Clinical Trials in Italy / NCT06823960
Recruiting Observational

Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)

NCT06823960 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-12-09
Last updated
2025-02-12

Condition(s) studied

Marginal Zone Lymphoma(MZL)

Study summary

Observational, non-interventional, retrospective, multicentre study focusing on efficacy and safety of zanubrutinib in daily clinical practice in patients with relapsed/refractory (R/R) marginal zone lymphoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed diagnosis of relapsed/refractory marginal zone lymphoma 2. Patients who received at least one dose of zanubrutinib under the Named patient program (D.M. 7 Sep 2017), between January 2021 and October 2023 3) Age≥18 at start of zanubrutinib therapy. 4) Signature of written informed consent to study participation and personal data processing. Exclusion Criteria: 1\) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.

Primary outcome measure(s)

  • Overall response rate (ORR) — through the duration of study, an average of 6 months
    the sum of the Complete Response \[CR\] and Partial Response \[PR\]) in accordance with the Lugano Classification

Trial sites (15)

FacilityCityRegionStatus
AOU SS Antonio e Biagio e Cesare Arrigo Alessandria Alessandria Not Yet Recruiting
IRCCS-AOU di Bologna Bologna Bologna Not Yet Recruiting
P.O. Garibaldi-Nesima_UOC Ematologia Catania Catania Not Yet Recruiting
AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia Cosenza Cosenza Not Yet Recruiting
AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche Ferrara Ferrara Not Yet Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS Meldola Forlì Cesena Recruiting
Istituto Clinico Humanitas IRCCS - UO Ematologia Milan Milano Not Yet Recruiting
ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia Milan MIlano Not Yet Recruiting
IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1 Padova Padova Not Yet Recruiting
Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico Palermo Palermo Not Yet Recruiting
Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna Ravenna Ravenna Not Yet Recruiting
Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative Roma Roma Not Yet Recruiting
AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia Torino Torino Not Yet Recruiting
Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina Treviso Treviso Not Yet Recruiting
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia Trieste Trieste Not Yet Recruiting

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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 NCT06823960 on ClinicalTrials.gov ↗ ← All trials in Italy