Assessing the effectiveness and safety of zanubrutinib for marginal zone lymphoma patients in Italy
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)
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 |
|---|---|
| Enrollment | 59 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | zanubrutinib |
| Locations | 15 sites (Alessandria, Alessandria and 14 other locations) |
| Trial ID | NCT06823960 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have participated in a clinical trial involving zanubrutinib will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Alessandria, Alessandria and 14 other locations
- 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)
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS — Meldola, Forlì Cesena, Italy (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.