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

IRCCS Azienda Ospedaliero-Universitaria di Bologna59 enrolled

Overview

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.

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

Conditions

Marginal Zone Lymphoma(MZL)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

AOU SS Antonio e Biagio e Cesare Arrigo

Alessandria, Alessandria, Italy

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Overall response rate (ORR)

the sum of the Complete Response \[CR\] and Partial Response \[PR\]) in accordance with the Lugano Classification

Time frame: through the duration of study, an average of 6 months