Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Marginal Zone Lymphoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment59 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Drugs / interventionszanubrutinib
Locations15 sites (Alessandria, Alessandria and 14 other locations)
StatusRecruiting
StartedDecember 9, 2024
Main results expectedJune 2025
Study endsJune 2025
Registry record updatedFebruary 12, 2025
Trial IDNCT06823960 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

  • 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
  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.