Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT06823960
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'through the duration of study, an average of 6 months', 'description': 'the sum of the Complete Response \\[CR\\] and Partial Response \\[PR\\]) in accordance with the Lugano Classification'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DoR)', 'timeFrame': 'through the duration of study, an average of 6 months', 'description': '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'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'through the duration of study, an average of 6 months', 'description': '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'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'through the duration of study, an average of 6 months', 'description': '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'}, {'measure': 'Best response rate (BRR),', 'timeFrame': 'through the duration of study, an average of 6 months', 'description': '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'}, {'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'through the duration of study, an average of 6 months', 'description': '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'}, {'measure': 'Type, incidence, severity of any adverse events (AE)', 'timeFrame': 'from start of treatment to 30 days after last dose', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['zanubrutinib'], 'conditions': ['Marginal Zone Lymphoma(MZL)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of relapsed/refractory 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/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.'}, 'identificationModule': {'nctId': 'NCT06823960', 'acronym': 'ZanOs', 'briefTitle': 'Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ZanOs'}}, 'contactsLocationsModule': {'locations': [{'zip': '15121', 'city': 'Alessandria', 'state': 'Alessandria', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gioacchino Catania, MD', 'role': 'CONTACT', 'email': 'gioacchino.catania@ospedale.al.it', 'phone': '+39 0131207825'}, {'name': 'Gioacchino Catania', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU SS Antonio e Biagio e Cesare Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+39 0512143680'}, {'name': 'Alessandro Broccoli, MD', 'role': 'CONTACT', 'email': 'alessandro.broccoli6@unibo.it', 'phone': '+39 0512143680'}, {'name': 'Pier Luigi Zinzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS-AOU di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '95122', 'city': 'Catania', 'state': 'Catania', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ugo Consoli, MD', 'role': 'CONTACT', 'email': 'uconsoli@arnasgaribaldi.it', 'phone': '+39 0957595801'}, {'name': 'Ugo Consoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'P.O. Garibaldi-Nesima_UOC Ematologia', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '87100', 'city': 'Cosenza', 'state': 'Cosenza', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Gentile, MD', 'role': 'CONTACT', 'email': 'm.gentile@aocs.it', 'phone': '+39 098421180'}, {'name': 'MAssimo Gentile, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'zip': '44124', 'city': 'Ferrara', 'state': 'Ferrara', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulia Daghia, MD', 'role': 'CONTACT', 'email': 'giulia.daghia@ospfe.it', 'phone': '+39 0532236092'}, {'name': 'Giulia Daghia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '47017', 'city': 'Meldola', 'state': 'Forlì Cesena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Malaspina, MD', 'role': 'CONTACT', 'email': 'francesco.malaspina@irst.emr.it', 'phone': '+39 0543739100'}, {'name': 'Francesco Malaspina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20089', 'city': 'Milan', 'state': 'Milano', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Magagnoli', 'role': 'CONTACT', 'email': 'massimo.magagnoli@humanitas.it', 'phone': '39 0282244533'}, {'name': 'Massimo Magagnoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Clinico Humanitas IRCCS - UO Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20162', 'city': 'Milan', 'state': 'MIlano', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marina Deodato, MD', 'role': 'CONTACT', 'email': 'marina.deodato@ospedaleniguarda.it', 'phone': '02 6444.2668'}, {'name': 'Marina Deodato, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '35128', 'city': 'Padua', 'state': 'Padova', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Dario Marino, MD', 'role': 'CONTACT', 'email': 'dario.marino@iov.veneto.it', 'phone': '+39 0498215953'}, {'name': 'Daio Marino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '90146', 'city': 'Palermo', 'state': 'Palermo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Caterina Patti, MD', 'role': 'CONTACT', 'email': 'k.patti@villasofia.it', 'phone': '+39 0916802642'}, {'name': 'Caterina Patti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '48121', 'city': 'Ravenna', 'state': 'Ravenna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'MOnica Tani', 'role': 'CONTACT', 'email': 'monica.tani@auslromagna.it', 'phone': '+39 0544 285752'}, {'name': 'Monica Tani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '00133', 'city': 'Roma', 'state': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vito Mario Rapisarda, MD', 'role': 'CONTACT', 'email': 'gruppoarcobaleno@ptvonline.it', 'phone': '+39 06 20903224'}, {'name': 'Vito Mario Rapisarda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione PTV Policlinico Tor Vergata- U.O.C. 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