[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579412":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":28,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":46,"responsibleParty":282,"collaborators":28,"id":284,"slug":28,"hasResults":285,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":285,"sex":291,"minAge":292,"maxAge":28,"enrollmentInfo":293,"targetDuration":28,"studyType":296,"phases":28,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":128,"whyStopped":28,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,19,21,23,25],{"measure":15,"description":16,"timeFrame":12},"Duration of response (DoR)","To evaluate safety and tollerability of zanubrutinib in patients with relapsed\u002Frefractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program",{"measure":18,"description":16,"timeFrame":12},"Progression Free Survival (PFS)",{"measure":20,"description":16,"timeFrame":12},"Overall Survival (OS)",{"measure":22,"description":16,"timeFrame":12},"Best response rate (BRR),",{"measure":24,"description":16,"timeFrame":12},"Disease Free Survival (DFS)",{"measure":26,"description":16,"timeFrame":27},"Type, incidence, severity of any adverse events (AE)","from start of treatment to 30 days after last dose",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","RETROSPECTIVE","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.","Patients with relapsed\u002Frefractory 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.",[35],{"name":36,"affiliation":5,"role":37},"Pier Luigi Zinzani, MD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":28,"email":42},"CONTACT","+39 0512143680","pierluigi.zinzani@unibo.it",{"name":44,"role":40,"phone":41,"phoneExt":28,"email":45},"Alessandro Broccoli, MD","alessandro.broccoli6@unibo.it",[47,67,80,95,111,126,143,160,173,189,204,220,235,251,267],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"AOU SS Antonio e Biagio e Cesare Arrigo","NOT_YET_RECRUITING","Alessandria","15121","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],8.61007,44.90924,{"lat":58,"lon":57},[61,65],{"name":62,"role":40,"phone":63,"phoneExt":28,"email":64},"Gioacchino Catania, MD","+39 0131207825","gioacchino.catania@ospedale.al.it",{"name":66,"role":37,"phone":28,"phoneExt":28,"email":28},"Gioacchino Catania",{"facility":68,"status":49,"city":69,"state":69,"zip":70,"country":52,"countryCode":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"IRCCS-AOU di Bologna","Bologna","40138",{"type":55,"coordinates":72},[73,74],11.33875,44.49381,{"lat":74,"lon":73},[77,78,79],{"name":36,"role":40,"phone":41,"phoneExt":28,"email":42},{"name":44,"role":40,"phone":41,"phoneExt":28,"email":45},{"name":36,"role":37,"phone":28,"phoneExt":28,"email":28},{"facility":81,"status":49,"city":82,"state":82,"zip":83,"country":52,"countryCode":53,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"P.O. Garibaldi-Nesima_UOC Ematologia","Catania","95122",{"type":55,"coordinates":85},[86,87],15.07041,37.49223,{"lat":87,"lon":86},[90,94],{"name":91,"role":40,"phone":92,"phoneExt":28,"email":93},"Ugo Consoli, MD","+39 0957595801","uconsoli@arnasgaribaldi.it",{"name":91,"role":37,"phone":28,"phoneExt":28,"email":28},{"facility":96,"status":49,"city":97,"state":97,"zip":98,"country":52,"countryCode":53,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"AO di Cosenza, P.O. \"Annunziata\" - UOC di Ematologia","Cosenza","87100",{"type":55,"coordinates":100},[101,102],16.25307,39.2989,{"lat":102,"lon":101},[105,109],{"name":106,"role":40,"phone":107,"phoneExt":28,"email":108},"Massimo Gentile, MD","+39 098421180","m.gentile@aocs.it",{"name":110,"role":37,"phone":28,"phoneExt":28,"email":28},"MAssimo Gentile, MD",{"facility":112,"status":49,"city":113,"state":113,"zip":114,"country":52,"countryCode":53,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche","Ferrara","44124",{"type":55,"coordinates":116},[117,118],11.62057,44.83804,{"lat":118,"lon":117},[121,125],{"name":122,"role":40,"phone":123,"phoneExt":28,"email":124},"Giulia Daghia, MD","+39 0532236092","giulia.daghia@ospfe.it",{"name":122,"role":37,"phone":28,"phoneExt":28,"email":28},{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":52,"countryCode":53,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Istituto Romagnolo per lo Studio dei Tumori \"Dino Amadori\" - IRST IRCCS","RECRUITING","Meldola","Forlì Cesena","47017",{"type":55,"coordinates":133},[134,135],12.0626,44.12775,{"lat":135,"lon":134},[138,142],{"name":139,"role":40,"phone":140,"phoneExt":28,"email":141},"Francesco Malaspina, MD","+39 0543739100","francesco.malaspina@irst.emr.it",{"name":139,"role":37,"phone":28,"phoneExt":28,"email":28},{"facility":144,"status":49,"city":145,"state":146,"zip":147,"country":52,"countryCode":53,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Istituto Clinico Humanitas IRCCS - UO Ematologia","Milan","Milano","20089",{"type":55,"coordinates":149},[150,151],12.59836,42.78235,{"lat":151,"lon":150},[154,158],{"name":155,"role":40,"phone":156,"phoneExt":28,"email":157},"Massimo Magagnoli","39 0282244533","massimo.magagnoli@humanitas.it",{"name":159,"role":37,"phone":28,"phoneExt":28,"email":28},"Massimo Magagnoli, MD",{"facility":161,"status":49,"city":145,"state":162,"zip":163,"country":52,"countryCode":53,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},"ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia","MIlano","20162",{"type":55,"coordinates":165},[150,151],{"lat":151,"lon":150},[168,172],{"name":169,"role":40,"phone":170,"phoneExt":28,"email":171},"Marina Deodato, MD","02 6444.2668","marina.deodato@ospedaleniguarda.it",{"name":169,"role":37,"phone":28,"phoneExt":28,"email":28},{"facility":174,"status":49,"city":175,"state":175,"zip":176,"country":52,"countryCode":53,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1","Padova","35128",{"type":55,"coordinates":178},[179,180],11.14261,44.38225,{"lat":180,"lon":179},[183,187],{"name":184,"role":40,"phone":185,"phoneExt":28,"email":186},"Dario Marino, MD","+39 0498215953","dario.marino@iov.veneto.it",{"name":188,"role":37,"phone":28,"phoneExt":28,"email":28},"Daio Marino, MD",{"facility":190,"status":49,"city":191,"state":191,"zip":192,"country":52,"countryCode":53,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico","Palermo","90146",{"type":55,"coordinates":194},[195,196],13.3636,38.1166,{"lat":196,"lon":195},[199,203],{"name":200,"role":40,"phone":201,"phoneExt":28,"email":202},"Caterina Patti, MD","+39 0916802642","k.patti@villasofia.it",{"name":200,"role":37,"phone":28,"phoneExt":28,"email":28},{"facility":205,"status":49,"city":206,"state":206,"zip":207,"country":52,"countryCode":53,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna","Ravenna","48121",{"type":55,"coordinates":209},[210,211],12.20121,44.41344,{"lat":211,"lon":210},[214,218],{"name":215,"role":40,"phone":216,"phoneExt":28,"email":217},"MOnica Tani","+39 0544 285752","monica.tani@auslromagna.it",{"name":219,"role":37,"phone":28,"phoneExt":28,"email":28},"Monica Tani, MD",{"facility":221,"status":49,"city":222,"state":222,"zip":223,"country":52,"countryCode":53,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative","Roma","00133",{"type":55,"coordinates":225},[226,227],11.10642,44.99364,{"lat":227,"lon":226},[230,234],{"name":231,"role":40,"phone":232,"phoneExt":28,"email":233},"Vito Mario Rapisarda, MD","+39 06 20903224","gruppoarcobaleno@ptvonline.it",{"name":231,"role":37,"phone":28,"phoneExt":28,"email":28},{"facility":236,"status":49,"city":237,"state":237,"zip":238,"country":52,"countryCode":53,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"AOU Città della Salute e della Scienza, \"Le Molinette\" - Divisione di Ematologia","Torino","10126",{"type":55,"coordinates":240},[241,242],11.99138,44.88856,{"lat":242,"lon":241},[245,249],{"name":246,"role":40,"phone":247,"phoneExt":28,"email":248},"Candida Vitale, MD","+39 0116331442","candida.vitale@unito.it",{"name":250,"role":37,"phone":28,"phoneExt":28,"email":28},"Candida Vitale",{"facility":252,"status":49,"city":253,"state":253,"zip":254,"country":52,"countryCode":53,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina","Treviso","31100",{"type":55,"coordinates":256},[257,258],12.2416,45.66673,{"lat":258,"lon":257},[261,265],{"name":262,"role":40,"phone":263,"phoneExt":28,"email":264},"Endri Mauro","+39 0422322221","endri.mauro@aulss2.veneto.it",{"name":266,"role":37,"phone":28,"phoneExt":28,"email":28},"Endri Mauro, MD",{"facility":268,"status":49,"city":269,"state":269,"zip":270,"country":52,"countryCode":53,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia","Trieste","34128",{"type":55,"coordinates":272},[273,274],13.77678,45.64953,{"lat":274,"lon":273},[277,281],{"name":278,"role":40,"phone":279,"phoneExt":28,"email":280},"Elisa Lucchini, MD","+39 0403992888","elisa.lucchini@asugi.sanita.fvg.it",{"name":278,"role":37,"phone":28,"phoneExt":28,"email":28},{"type":283,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100579412",false,"NCT06823960","Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)","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)","ZanOs","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of relapsed\u002Frefractory marginal zone lymphoma\n2. 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.\n\nExclusion Criteria:\n\n1\\) relapsed\u002Frefractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.","ALL","18 Years",{"count":294,"type":295},59,"ESTIMATED","OBSERVATIONAL","Observational, non-interventional, retrospective, multicentre study focusing on efficacy and safety of zanubrutinib in daily clinical practice in patients with relapsed\u002Frefractory (R\u002FR) marginal zone lymphoma.",[299],"Marginal Zone Lymphoma(MZL)",[301],"zanubrutinib","2025-02-11",{"date":304,"type":305},"2025-02-12","ACTUAL",{"date":307,"type":305},"2024-12-09",{"date":309,"type":295},"2025-06",{"name":5,"class":6},15]