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

NCT06823960 | Recruiting

• 1 other identifier: ZanOs
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Marginal Zone Lymphoma(MZL)

Keywords

zanubrutinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of response (DoR)

  through the duration of study, an average of 6 months

• Progression Free Survival (PFS)

  through the duration of study, an average of 6 months

• Overall Survival (OS)

  through the duration of study, an average of 6 months

• Best response rate (BRR),

  through the duration of study, an average of 6 months

• Disease Free Survival (DFS)

  through the duration of study, an average of 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histologically confirmed diagnosis of relapsed/refractory marginal zone lymphoma
• 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.

You may not qualify if:

• \) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (15)

AOU SS Antonio e Biagio e Cesare Arrigo

Alessandria, Alessandria, 15121, Italy

NOT YET RECRUITING

IRCCS-AOU di Bologna

Bologna, Bologna, 40138, Italy

NOT YET RECRUITING

P.O. Garibaldi-Nesima_UOC Ematologia

Catania, Catania, 95122, Italy

NOT YET RECRUITING

AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia

Cosenza, Cosenza, 87100, Italy

NOT YET RECRUITING

AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche

Ferrara, Ferrara, 44124, Italy

NOT YET RECRUITING

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS

Meldola, Forlì Cesena, 47017, Italy

RECRUITING

Istituto Clinico Humanitas IRCCS - UO Ematologia

Milan, Milano, 20089, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia

Milan, MIlano, 20162, Italy

NOT YET RECRUITING

IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1

Padua, Padova, 35128, Italy

NOT YET RECRUITING

Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico

Palermo, Palermo, 90146, Italy

NOT YET RECRUITING

Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna

Ravenna, Ravenna, 48121, Italy

NOT YET RECRUITING

Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative

Roma, Roma, 00133, Italy

NOT YET RECRUITING

AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia

Torino, Torino, 10126, Italy

NOT YET RECRUITING

Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina

Treviso, Treviso, 31100, Italy

NOT YET RECRUITING

Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia

Trieste, Trieste, 34128, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+39 0512143680; pierluigi.zinzani@unibo.it

Alessandro Broccoli, MD

CONTACT

+39 0512143680; alessandro.broccoli6@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 12, 2025
• Study Start: December 9, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (15)