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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Marginal Zone Lymphoma(MZL)

Detailed Description

Due to the rarity of the condition and the novelty of its application, the study is intended to be exploratory, with the aim of providing interim evidence on which to plan future studies in larger populations. Data will be collected from the start of therapy until 6 months after the end of therapy, when applicable.

• Study Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

• Study Contact: Name: Pier Luigi Zinzani, MD; Phone Number: +39 0512143680; Email: pierluigi.zinzani@unibo.it
• Study Contact Backup: Name: Alessandro Broccoli, MD; Phone Number: +39 0512143680; Email: alessandro.broccoli6@unibo.it

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • Not yet recruiting
    • AOU SS Antonio e Biagio e Cesare Arrigo
    • Contact: Gioacchino Catania, MD; Phone Number: +39 0131207825; Email: gioacchino.catania@ospedale.al.it
    • Contact: Gioacchino Catania
  • Bologna, Italy, 40138
    • Not yet recruiting
    • IRCCS-AOU di Bologna
    • Contact: Pier Luigi Zinzani, MD; Phone Number: +39 0512143680; Email: pierluigi.zinzani@unibo.it
    • Contact: Pier Luigi Zinzani, MD
    • Contact: Alessandro Broccoli, MD; Phone Number: +39 0512143680; Email: alessandro.broccoli6@unibo.it
  • Catania, Italy, 95122
    • Not yet recruiting
    • P.O. Garibaldi-Nesima_UOC Ematologia
    • Contact: Ugo Consoli, MD
    • Contact: Ugo Consoli, MD; Phone Number: +39 0957595801; Email: uconsoli@arnasgaribaldi.it
  • Cosenza, Italy, 87100
    • Not yet recruiting
    • AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia
    • Contact: MAssimo Gentile, MD
    • Contact: Massimo Gentile, MD; Phone Number: +39 098421180; Email: m.gentile@aocs.it
  • Ferrara, Italy, 44124
    • Not yet recruiting
    • AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche
    • Contact: Giulia Daghia, MD
    • Contact: Giulia Daghia, MD; Phone Number: +39 0532236092; Email: giulia.daghia@ospfe.it
  • Milano, Italy, 20089
    • Not yet recruiting
    • Istituto Clinico Humanitas IRCCS - UO Ematologia
    • Contact: Massimo Magagnoli; Phone Number: 39 0282244533; Email: massimo.magagnoli@humanitas.it
    • Contact: Massimo Magagnoli, MD
  • Milano, Italy, 20162
    • Not yet recruiting
    • ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia
    • Contact: Marina Deodato, MD; Phone Number: 02 6444.2668; Email: marina.deodato@ospedaleniguarda.it
    • Contact: Marina Deodato, MD
  • Padova, Italy, 35128
    • Not yet recruiting
    • IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1
    • Contact: Dario Marino, MD; Phone Number: +39 0498215953; Email: dario.marino@iov.veneto.it
    • Contact: Daio Marino, MD
  • Palermo, Italy, 90146
    • Not yet recruiting
    • Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico
    • Contact: Caterina Patti, MD
    • Contact: Caterina Patti, MD; Phone Number: +39 0916802642; Email: k.patti@villasofia.it
  • Ravenna, Italy, 48121
    • Not yet recruiting
    • Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna
    • Contact: Monica Tani, MD
    • Contact: MOnica Tani; Phone Number: +39 0544 285752; Email: monica.tani@auslromagna.it
  • Roma, Italy, 00133
    • Not yet recruiting
    • Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative
    • Contact: Vito Mario Rapisarda, MD; Phone Number: +39 06 20903224; Email: gruppoarcobaleno@ptvonline.it
    • Contact: Vito Mario Rapisarda, MD
  • Torino, Italy, 10126
    • Not yet recruiting
    • AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia
    • Contact: Candida Vitale, MD; Phone Number: +39 0116331442; Email: candida.vitale@unito.it
    • Contact: Candida Vitale
  • Treviso, Italy, 31100
    • Not yet recruiting
    • Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina
    • Contact: Endri Mauro; Phone Number: +39 0422322221; Email: endri.mauro@aulss2.veneto.it
    • Contact: Endri Mauro, MD
  • Trieste, Italy, 34128
    • Not yet recruiting
    • Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia
    • Contact: Elisa Lucchini, MD; Phone Number: +39 0403992888; Email: elisa.lucchini@asugi.sanita.fvg.it
    • Contact: Elisa Lucchini, MD
  • Forlì Cesena
    • Meldola, Forlì Cesena, Italy, 47017
      • Recruiting
      • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
      • Contact: Francesco Malaspina, MD; Phone Number: +39 0543739100; Email: francesco.malaspina@irst.emr.it
      • Contact: Francesco Malaspina, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under the Named patient program (D.M. 7 Sep 2017), between January 2021 and October 2023.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	the sum of the Complete Response [CR] and Partial Response [PR]) in accordance with the Lugano Classification	through the duration of study, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DoR)	To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program	through the duration of study, an average of 6 months
Progression Free Survival (PFS)	To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program	through the duration of study, an average of 6 months
Overall Survival (OS)	To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program	through the duration of study, an average of 6 months
Best response rate (BRR),	To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program	through the duration of study, an average of 6 months
Disease Free Survival (DFS)	To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program	through the duration of study, an average of 6 months
Type, incidence, severity of any adverse events (AE)	To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program	from start of treatment to 30 days after last dose

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: zanubrutinib
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, B-Cell, Marginal Zone
• Other Study ID Numbers: ZanOs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No