Clinical trial NCT06823960: Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Marginal Zone Lymphoma(MZL)
Keywords: zanubrutinib
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: through the duration of study, an average of 6 months
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: through the duration of study, an average of 6 months
measure: Progression Free Survival (PFS)
timeFrame: through the duration of study, an average of 6 months
measure: Overall Survival (OS)
timeFrame: through the duration of study, an average of 6 months
measure: Best response rate (BRR),
timeFrame: through the duration of study, an average of 6 months
measure: Disease Free Survival (DFS)
timeFrame: through the duration of study, an average of 6 months
measure: Type, incidence, severity of any adverse events (AE)
timeFrame: from start of treatment to 30 days after last dose
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
state: Forlì Cesena
city: Alessandria
country: Italy
facility: AOU SS Antonio e Biagio e Cesare Arrigo
city: Bologna
country: Italy
facility: IRCCS-AOU di Bologna
city: Catania
country: Italy
facility: P.O. Garibaldi-Nesima_UOC Ematologia
city: Cosenza
country: Italy
facility: AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia
city: Ferrara
country: Italy
facility: AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche
city: Milano
country: Italy
facility: Istituto Clinico Humanitas IRCCS - UO Ematologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina
city: Trieste
country: Italy
facility: Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: