Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
NCT ID: NCT04034056
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
299 participants
OBSERVATIONAL
2019-09-02
2024-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Obinutuzumab
Obinutuzumab
Induction phase: 1000 milligram (mg) intravenously (IV) on Day 1, 8, 15 of Cycle 1 an Day 1 of Cycles 2-6 or 2-8. Maintenance phase: 1000 mg IV every 2 months for 2 years or until disease progression (whatever occurs earlier).
Interventions
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Obinutuzumab
Induction phase: 1000 milligram (mg) intravenously (IV) on Day 1, 8, 15 of Cycle 1 an Day 1 of Cycles 2-6 or 2-8. Maintenance phase: 1000 mg IV every 2 months for 2 years or until disease progression (whatever occurs earlier).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Concomitant participation in an interventional clinical study;
* Participants not receiving treatment for untreated follicular lymphoma with Obinutuzumab according to standard of care and in line with local labeling.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Ospedale Civile Dello Spirito Santo
Pescara, Abruzzo, Italy
AOU Policlinico Consorziale
Bari, Apulia, Italy
Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
Bari, Apulia, Italy
Asl Bat Ospedale Mons. Dimiccoli
Barletta, Apulia, Italy
Ospedale Vito Fazzi
Lecce, Apulia, Italy
Casa Sollievo della Sofferenza U.O. Ematologia
San Giovanni Rotondo (FG), Apulia, Italy
Az. Osp. C. Panico
Tricase - LE, Apulia, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, Calabria, Italy
Azienda Ospedaliera S.G. Moscati
Avellino, Campania, Italy
A.O. S. Anna e San Sebastiano
Caserta, Campania, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Napoli, Campania, Italy
Ospedale Cardarelli
Napoli, Campania, Italy
Ospedale "A.Tortora" ? Ematologia
Pagani (Sa), Campania, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
Bologna, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, Italy
Az. Osp. Arcispedale S. Maria Nuova
Reggio Emilia, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, Italy
Univesità La Sapienza Policlinico Umberto I
Rome, Lazio, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
Rome, Lazio, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
UOC Oncoematologia, Ospedale Maggiore Policlinico
Milano Policlinico Maggiore, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese, Lombardy, Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, Piedmont, Italy
Città della Salute e della Scienza di Torino. Presidio Molinette
Turin, Piedmont, Italy
Ospedale Businco
Cagliari, Sardinia, Italy
Osp. San Francesco
Nuoro, Sardinia, Italy
ARNAS Garibaldi
Catania, Sicily, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicily, Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, Sicily, Italy
Casa Di Cura La Maddalena
Palermo, Sicily, Italy
Ospedali Riuniti Umberto I
Ancona, The Marches, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
USL 4 di Prato - Nuovo Ospeale di Prato
Prato, Tuscany, Italy
A.O. Universitaria Senese
Siena, Tuscany, Italy
Azienda Ospedaliera S. Maria della Misericordia
Perugia, Umbria, Italy
Az. Osp. S. Maria
Terni, Umbria, Italy
Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
Padua, Veneto, Italy
Ospedale Ca Foncello
Treviso, Veneto, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, Veneto, Italy
Countries
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References
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Pinto A, Caltagirone M, Battista M, Gazzoli GC, Patti C, Pennese E, De Lorenzo S, Pavone V, Merli M, Chiarenza A, Gorgone AG, Piazza F, Puccini B, Noto A, Arcaini L, De Filippi R, Zinzani PL, Ferreri AJM, Ladetto M, Ferrari S, Gritti G. Exposure to obinutuzumab does not affect outcomes of SARS-CoV-2 infection in vaccinated patients with newly diagnosed advanced-stage follicular lymphoma. Br J Haematol. 2024 Dec;205(6):2219-2227. doi: 10.1111/bjh.19661. Epub 2024 Jul 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ML41215
Identifier Type: -
Identifier Source: org_study_id
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