Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT05100056
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2021-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Assessed by Investigator', 'timeFrame': 'From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months)', 'description': 'PFS will be assessed by investigator and defined as the time from the first dose of BV post ASCT until the first occurrence of disease progression or relapse, or death for any reason. Disease progression is at least a 50 percent (%) increase in the size of lesions, or the occurrence of new lesions. It will be analyzed using Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From initiation of BV treatment until death from any cause (up to 36 months)', 'description': 'OS is defined as the time from initiation of therapy to death from any cause. It will be analyzed using Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Hodgkin Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/618310f4eb0e19002afd69ff', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': "The main aim is to check how effective BV is for treating adults with HL.\n\nStudy medication will be prescribed according to the clinic's standard practice.\n\nParticipants will visit the study clinic 5 times, once every 12 weeks. When study treatment has completed, a follow-up visit will be scheduled every 3 months during the first year and every 4-6 months during the next year.", 'detailedDescription': 'This is a prospective, observational study in participants with HL who underwent or are candidates for ASCT and receiving or will receive the standard treatment of BV. This study will assess the safety profile and effectiveness of BV in pre and post-ASCT in the real-world clinical practice.\n\nThe study will enroll approximately 70 participants.\n\nThe data will be collected and recorded in electronic case report forms (e-CRFs) in scope of National Drug Program (NDP). All the participants will be assigned to two observational cohorts:\n\n* HL Participants: BV Salvage Pre-ASCT\n* HL Participants: BV Consolidation Treatment Post-ASCT\n\nThis multi-center trial will be conducted in Poland. All participants will be followed up for 24 months. The overall duration of the study will be approximately 4.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with HL (previously enrolled in BV HL NDP) who underwent or are candidates for ASCT will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Adult participant (aged greater than or equal to \\[\\>=18\\] years) that underwent or are candidates for ASCT and were enrolled in BV HL NDP receiving treatment according to the Summary of Product Characteristics for Adcetris and NDP.\n\nExclusion Criteria:\n\n1. Currently participates or plans to participate in any interventional clinical trial.\n2. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study."}, 'identificationModule': {'nctId': 'NCT05100056', 'acronym': 'BV-MAZOVIA', 'briefTitle': "A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': "Effectiveness and Safety of Consolidative Brentuximab Vedotin (BV) Treatment Administered to Hodgkin's Lymphoma (HL) Patients That Had Undergone Autologous Stem Cell Transplant (ASCT). Prospective, Multicenter, Observational Study", 'orgStudyIdInfo': {'id': 'Brentuximab-5018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HL Participants: BV Salvage Pre-ASCT', 'description': 'Participants diagnosed with HL who undergone or undergoing pre-ASCT BV salvage and continue with post-ASCT treatment will be observed prospectively over 24-month period after treatment cessation.', 'interventionNames': ['Other: No Intervention']}, {'label': 'HL Participants: BV Consolidation Treatment Post-ASCT', 'description': 'Participants diagnosed with HL who undergone or undergoing post-ASCT BV consolidation treatment will be observed prospectively over 24-month period after treatment cessation.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This is a non-interventional study.', 'armGroupLabels': ['HL Participants: BV Consolidation Treatment Post-ASCT', 'HL Participants: BV Salvage Pre-ASCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-556', 'city': 'Wroclaw', 'state': 'Dolnoslskie', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'khn@usk.wroc.pl', 'phone': '48 71 784 25 76'}, {'name': 'Tomasz Wrobel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '61-848', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'hematologia.sekretariat@skpp.edu.pl', 'phone': '48 61 854 93 83'}, {'name': 'Lidia Gil', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '31-115', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'kontakt@onkologia.krakow.pl', 'phone': '48 12 63 48 268'}, {'name': 'Monika Dlugosz-Danecka', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-501', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'rejestracja.hematologia@su.krakow.pl', 'phone': '48 12 424 76 32'}, {'name': 'Agnieszka Giza', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-090', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'cozl@cozl.eu', 'phone': '48 81 454 1226'}, {'name': 'Marta Morawska', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '97-200', 'city': 'Tomaszow Mazowiecki', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'sekretariat.tomaszow@nu-med.pl', 'phone': '48 44 786 81 00'}, {'name': 'Ewa Chmielowska', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki'}, {'zip': '02-097', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'kho.csk@uckwum.pl', 'phone': '48 22 599 28 18'}, {'name': 'Joanna Drozd-Sokolowska', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniwersyteckie Centrum Kliniczne WUM', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-776', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'hemsek@ihit.waw.pl', 'phone': '48 22 34 96 334'}, {'name': 'Agnieszka Kolkowska-Lesniak', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instytut Hematologii i Transfuzjologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-781', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'klinikachloniakow@pib-nio.pl', 'phone': '48 22 546 20 00'}, {'name': 'Ewa Paszkiewicz-Kozik', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '80-214', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'info@uck.gda.pl', 'phone': '48 58 349 20 00'}, {'name': 'Jan Zaucha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniwersyteckie Centrum Kliniczne, Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-027', 'city': 'Katowice', 'state': 'Slskie', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'klinhem@sum.edu.pl', 'phone': '48 32 256 28 58'}, {'name': 'Ryszard Wichary', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '10-228', 'city': 'Olsztyn', 'state': 'Warmian-Masurian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'sek.hematologia@poliklinika.net', 'phone': '48 89 539 81 33'}, {'name': 'Edyta Subocz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '93-513', 'city': 'Lodz', 'state': 'Łódź Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'szpital@kopernik.lodz.pl', 'phone': '48 42 689 50 00'}, {'name': 'Magdalena Witkowska', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Takeda Contact', 'role': 'CONTACT', 'email': 'medinfoUS@takeda.com', 'phone': '+1-877-825-3327'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}