Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Marginal Zone Lymphoma(MZL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
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.
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.
Primary outcome measures
- Overall response rate (ORR) [Time frame: through the duration of study, an average of 6 months]
Secondary outcome measures (6)
- Duration of response (DoR) [Time frame: through the duration of study, an average of 6 months]
- Progression Free Survival (PFS) [Time frame: through the duration of study, an average of 6 months]
- Overall Survival (OS) [Time frame: through the duration of study, an average of 6 months]
- Best response rate (BRR), [Time frame: through the duration of study, an average of 6 months]
- Disease Free Survival (DFS) [Time frame: through the duration of study, an average of 6 months]
- Type, incidence, severity of any adverse events (AE) [Time frame: from start of treatment to 30 days after last dose]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
1\) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 15 centers
- AOU SS Antonio e Biagio e Cesare Arrigo — Alessandria
- IRCCS-AOU di Bologna — Bologna
- P.O. Garibaldi-Nesima_UOC Ematologia — Catania
- AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia — Cosenza
- AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche — Ferrara
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS — Meldola
- Istituto Clinico Humanitas IRCCS - UO Ematologia — Milan
- ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia — Milan
- … and 7 more centers
Identifiers
NCT: NCT06823960 · ZanOs