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

Recruiting

• Conditions: Marginal Zone Lymphoma(MZL)

• Registration Number: NCT06823960
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-09
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	through the duration of study, an average of 6 months	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
Progression Free Survival (PFS)	through the duration of study, an average of 6 months	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
Best response rate (BRR),	through the duration of study, an average of 6 months	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
Overall Survival (OS)	through the duration of study, an average of 6 months	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
Disease Free Survival (DFS)	through the duration of study, an average of 6 months	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
Type, incidence, severity of any adverse events (AE)	from start of treatment to 30 days after last dose	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

Trial Locations

Locations (15)

Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico; 🇮🇹 Palermo, Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS; 🇮🇹 Meldola, Forlì Cesena, Italy

AOU SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1; 🇮🇹 Padova, Italy

ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia; 🇮🇹 Milano, Italy

IRCCS-AOU di Bologna; 🇮🇹 Bologna, Italy

AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia; 🇮🇹 Cosenza, Italy

Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative; 🇮🇹 Roma, Italy

P.O. Garibaldi-Nesima_UOC Ematologia; 🇮🇹 Catania, Italy

AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche; 🇮🇹 Ferrara, Italy

Istituto Clinico Humanitas IRCCS - UO Ematologia; 🇮🇹 Milano, Italy

AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia; 🇮🇹 Torino, Italy

Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna; 🇮🇹 Ravenna, Italy

Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina; 🇮🇹 Treviso, Italy

Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia; 🇮🇹 Trieste, Italy