Assessing the effectiveness and safety of zanubrutinib for marginal zone lymphoma patients in Italy
Official title: An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06823960 · Data updated 2026-11-12
This study is trying to see how well and safely zanubrutinib works for people in Italy with relapsed or hard-to-treat marginal zone lymphoma who have already received treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 59 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | zanubrutinib |
| Locations | 15 sites (Alessandria, Alessandria and 14 other locations) |
| Status | Recruiting |
| Started | December 9, 2024 |
| Main results expected | June 2025 |
| Study ends | June 2025 |
| Registry record updated | February 12, 2025 |
| Trial ID | NCT06823960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with a histologically confirmed diagnosis of relapsed or refractory marginal zone lymphoma who have received zanubrutinib.
✕Probably not a fit
Patients who have participated in a clinical trial involving zanubrutinib will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the efficacy and safety of zanubrutinib in patients with relapsed or refractory marginal zone lymphoma who have been treated under the Named Patient Program in Italy. It is a retrospective, multicenter study that aims to gather real-world data on the drug's performance in clinical practice. Data will be collected from the initiation of therapy until six months after treatment completion, providing insights into the drug's effectiveness and safety profile in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide valuable evidence to support the use of zanubrutinib as a treatment option for patients with marginal zone lymphoma.
How similar studies have gone: While this study is exploratory due to the rarity of the condition, similar observational studies have shown promise in evaluating the effectiveness of new treatments in real-world settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
Meldola, Forlì Cesena, Italy Recruiting -
AOU SS Antonio e Biagio e Cesare Arrigo
Alessandria, Alessandria, Italy Not yet recruiting -
IRCCS-AOU di Bologna
Bologna, Bologna, Italy Not yet recruiting -
P.O. Garibaldi-Nesima_UOC Ematologia
Catania, Catania, Italy Not yet recruiting -
AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia
Cosenza, Cosenza, Italy Not yet recruiting -
AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche
Ferrara, Ferrara, Italy Not yet recruiting
Show 9 more locations
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Istituto Clinico Humanitas IRCCS - UO Ematologia
Milan, Milano, Italy Not yet recruiting -
ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia
Milan, MIlano, Italy Not yet recruiting -
IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1
Padova, Padova, Italy Not yet recruiting -
Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico
Palermo, Palermo, Italy Not yet recruiting -
Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna
Ravenna, Ravenna, Italy Not yet recruiting -
Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative
Roma, Roma, Italy Not yet recruiting -
AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia
Torino, Torino, Italy Not yet recruiting -
Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina
Treviso, Treviso, Italy Not yet recruiting -
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia
Trieste, Trieste, Italy Not yet recruiting
Study contacts
- Principal investigator: Pier Luigi Zinzani, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Pier Luigi Zinzani, MD
- Email: pierluigi.zinzani@unibo.it
- Phone: +39 0512143680
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Zanubrutinib plus Lenalidomide for frail elderly with newly diagnosed PCNSL
This study tests whether a combination of zanubrutinib and lenalidomide can help frail elderly patients with newly diagnosed primary CNS lymphoma.
-
Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients
This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.
-
MRD-guided Zanubrutinib + Sonrotoclax in new high-risk CLL/SLL
This trial tests a time-limited, MRD-guided combination therapy with zanubrutinib and sonrotoclax for adults up to 75 with previously untreated high-risk CLL/SLL.
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Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)
This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.
-
Pola-ZR-Glo for older patients with large B‑cell lymphoma
This trial will try combining polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab as first-line treatment for people aged 70 and older with newly diagnosed large B‑cell lymphoma who are unfit for standard chemo or decline immunochemotherapy.
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Orelabrutinib plus rituximab with optional lenalidomide for untreated marginal zone lymphoma using a response-adapted plan
This will test whether giving orelabrutinib with rituximab, and adding lenalidomide for those who don't fully respond, helps people with newly diagnosed marginal zone lymphoma achieve complete remissions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.