Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
URBAN
A Non-Interventional, Retrospective And Prospective, Multicenter, Single Arm Study Evaluating The Effectiveness And Safety Of Obinutuzumab In Patients With Previously Untreated Advanced Follicular Lymphoma
1 other identifier
observational
299
1 country
46
Brief Summary
To evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1L FL measured by the % of relapse within 24 months from start of therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
September 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2024
CompletedResults Posted
Study results publicly available
May 9, 2025
CompletedMay 9, 2025
May 1, 2025
4.6 years
July 23, 2019
April 16, 2025
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Progression of Disease at Year 2 (POD24)
POD24=time from date of treatment initiation with obinutuzumab until first documented PD/death due to PD, whichever occurs first, within 24 months from start of treatment with obinutuzumab. According to standard Cheson criteria \& Deauville 5-point scale, PD=20% increase in sum of longest diameters (LD) of target lesions; for small lymph nodes measuring \<15 millimeters (mm) post therapy, a minimum absolute increase of 5 mm \& LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \& any 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) results. Participants with no PD \& who didn't die due to PD/were lost to follow-up at time of analysis were censored at date of last tumor assessment where no progression was documented/last date of follow-up for disease, whichever was last. Participants without post-baseline tumor assessments were censored at time of their baseline visit unless death due to PD occurred prior to their first scheduled tumor assessment.
At Year 2
Secondary Outcomes (28)
Percentage of Participants With Progression-free Survival at Year 2 (PFS2)
At Year 2
Percentage of Participants With PFS at Year 3 (PFS3)
At Year 3
Time to Next Treatment (TTNT)
Up to approximately 56 months
Overall Survival (OS)
Up to approximately 56 months
Time From First Dose to Loss of Clinical Benefit (TTLCB)
Up to approximately 56 months
- +23 more secondary outcomes
Study Arms (1)
Obinutuzumab
Interventions
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
The patient population taking part in the study will comprise patients aged ≥ 18 years in first treatment for advanced FL, in which Obinutuzumab are administered in combination with chemotherapy during the induction phase, followed by Obinutuzumab maintenance therapy. This indication and treatment scheme is that approved by the EMA as per EU countries agency and AIFA as per Italian local agency.
You may qualify if:
- Signed Informed consent according to local regulations, after performing at least 2 cycles of induction treatment with Obinutuzumab and chemotherapy, within 1 year from beginning of treatment
You may not qualify if:
- Any contraindications to Obinutuzumab therapy according to local label for specific indication;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Ospedale Civile Dello Spirito Santo
Pescara, Abruzzo, 65100, Italy
AOU Policlinico Consorziale
Bari, Apulia, 70124, Italy
Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
Bari, Apulia, 70124, Italy
Asl Bat Ospedale Mons. Dimiccoli
Barletta, Apulia, 75121, Italy
Ospedale Vito Fazzi
Lecce, Apulia, 73100, Italy
Casa Sollievo della Sofferenza U.O. Ematologia
San Giovanni Rotondo (FG), Apulia, 71013, Italy
Az. Osp. C. Panico
Tricase - LE, Apulia, 73039, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, Calabria, 89100, Italy
Azienda Ospedaliera S.G. Moscati
Avellino, Campania, 83100, Italy
A.O. S. Anna e San Sebastiano
Caserta, Campania, 81100, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Napoli, Campania, 80131, Italy
Ospedale Cardarelli
Napoli, Campania, 80131, Italy
Ospedale "A.Tortora" ? Ematologia
Pagani (Sa), Campania, 84016, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
Bologna, Emilia-Romagna, 40138, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, 41100, Italy
Az. Osp. Arcispedale S. Maria Nuova
Reggio Emilia, Emilia-Romagna, 42100, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, 33081, Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, 33100, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Univesità La Sapienza Policlinico Umberto I
Rome, Lazio, 00161, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
Rome, Lazio, 189, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, 24127, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162, Italy
UOC Oncoematologia, Ospedale Maggiore Policlinico
Milano Policlinico Maggiore, Lombardy, 20122, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese, Lombardy, 21100, Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, Piedmont, 15121, Italy
Città della Salute e della Scienza di Torino. Presidio Molinette
Turin, Piedmont, 10126, Italy
Ospedale Businco
Cagliari, Sardinia, 09121, Italy
Osp. San Francesco
Nuoro, Sardinia, 08100, Italy
ARNAS Garibaldi
Catania, Sicily, 95122, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicily, 95123, Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, Sicily, 90127, Italy
Casa Di Cura La Maddalena
Palermo, Sicily, 90146, Italy
Ospedali Riuniti Umberto I
Ancona, The Marches, 60100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100, Italy
USL 4 di Prato - Nuovo Ospeale di Prato
Prato, Tuscany, 59100, Italy
A.O. Universitaria Senese
Siena, Tuscany, 53100, Italy
Azienda Ospedaliera S. Maria della Misericordia
Perugia, Umbria, 06100, Italy
Az. Osp. S. Maria
Terni, Umbria, 05100, Italy
Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
Padua, Veneto, DUMMY_VALUE, Italy
Ospedale Ca Foncello
Treviso, Veneto, 31100, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, Veneto, 37134, Italy
Related Publications (1)
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.
PMID: 39039666DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 26, 2019
Study Start
September 2, 2019
Primary Completion
April 22, 2024
Study Completion
April 22, 2024
Last Updated
May 9, 2025
Results First Posted
May 9, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).