Clinical trial NCT04034056: Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follicular Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: This observational study has been planned to evaluate the effectiveness of obinutuzumab in combination with chemotherapy in previously untreated advanced FL patients, in the real world setting in Italy. The study will allow to collect real-life data in a significant number of Italian patients when compared to participants in pivotal studies of obinutuzumab and thus will allow to verify in routine practice (after physician hands-on) the effectiveness and safety management in 50 reference sites all over the country.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Progression of Disease at Year 2 (POD24)
timeFrame: At Year 2
Secondary outcomes:
measure: Percentage of Participants With Progression-free Survival at Year 2 (PFS2)
timeFrame: At Year 2
measure: Percentage of Participants With PFS at Year 3 (PFS3)
timeFrame: At Year 3
measure: Time to Next Treatment (TTNT)
timeFrame: Up to approximately 56 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 56 months
measure: Time From First Dose to Loss of Clinical Benefit (TTLCB)
timeFrame: Up to approximately 56 months
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 56 months
measure: Percentage of Participants With CR
timeFrame: Up to approximately 56 months
measure: Percentage of Participants With CR at 30 Months (CR30)
timeFrame: At 30 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 56 months
measure: Time to Response (TTR)
timeFrame: Up to approximately 56 months
measure: Percentage of Participants With SD
timeFrame: Up to approximately 56 months
measure: Percentage of Participants With FDG-PET Response at End of Induction and End of Maintenance
timeFrame: Up to approximately 56 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)
measure: Number of Participants With Adverse Events of Special Interests (AESIs)
timeFrame: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)
measure: Number of Participants With Infusion-related Reactions (IRRs)
timeFrame: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)
measure: Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI)
timeFrame: At Year 2
measure: Percentage of Participants With PFS2 Stratified by ECOG PS
timeFrame: At Year 2
measure: Percentage of Participants With PFS2 Stratified by Age
timeFrame: At Year 2
measure: Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice
timeFrame: At Year 2
measure: Percentage of Participants With PFS2 Stratified by Hepatitis B Virus (HBV) Infection
timeFrame: At Year 2
measure: Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders
timeFrame: At Year 2
measure: Percentage of Participants With PFS3 Stratified by FLIPI
timeFrame: At Year 3
measure: Percentage of Participants With PFS3 Stratified by ECOG PS
timeFrame: At Year 3
measure: Percentage of Participants With PFS3 Stratified by Age
timeFrame: At Year 3
measure: Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice
timeFrame: At Year 3
measure: Percentage of Participants With PFS3 Stratified by HBV Infection
timeFrame: At Year 3
measure: Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders
timeFrame: At Year 3
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Ospedale Civile Dello Spirito Santo
state: Abruzzo
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli
state: Calabria
city: Avellino
country: Italy
facility: Azienda Ospedaliera S.G. Moscati
state: Campania
city: Caserta
country: Italy
facility: A.O. S. Anna e San Sebastiano
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale
state: Campania
city: Napoli
country: Italy
facility: Ospedale Cardarelli
state: Campania
city: Pagani (Sa)
country: Italy
facility: Ospedale "A.Tortora" ? Ematologia
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Az. Osp. Arcispedale S. Maria Nuova
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO)
state: Friuli-Venezia Giulia
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Univesità La Sapienza Policlinico Umberto I
state: Lazio
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
state: Lazio
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
state: Lombardia
city: Milano Policlinico Maggiore
country: Italy
facility: UOC Oncoematologia, Ospedale Maggiore Policlinico
state: Lombardia
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: Lombardia
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi
state: Lombardia
city: Ancona
country: Italy
facility: Ospedali Riuniti Umberto I
state: Marche
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
state: Piemonte
city: Torino
country: Italy
facility: Città della Salute e della Scienza di Torino. Presidio Molinette
state: Piemonte
city: Bari
country: Italy
facility: AOU Policlinico Consorziale
state: Puglia
city: Bari
country: Italy
facility: Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
state: Puglia
city: Barletta
country: Italy
facility: Asl Bat Ospedale Mons. Dimiccoli
state: Puglia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
state: Puglia
city: San Giovanni Rotondo (FG)
country: Italy
facility: Casa Sollievo della Sofferenza U.O. Ematologia
state: Puglia
city: Tricase - LE
country: Italy
facility: Az. Osp. C. Panico
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Businco
state: Sardegna
city: Nuoro
country: Italy
facility: Osp. San Francesco
state: Sardegna
city: Catania
country: Italy
facility: ARNAS Garibaldi
state: Sicilia
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
state: Sicilia
city: Palermo
country: Italy
facility: Azienda Ospedaliera Vincenzo Cervello
state: Sicilia
city: Palermo
country: Italy
facility: Casa Di Cura La Maddalena
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Prato
country: Italy
facility: USL 4 di Prato - Nuovo Ospeale di Prato
state: Toscana
city: Siena
country: Italy
facility: A.O. Universitaria Senese
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordia
state: Umbria
city: Terni
country: Italy
facility: Az. Osp. S. Maria
state: Umbria
city: Padova
country: Italy
facility: Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
state: Veneto
city: Treviso
country: Italy
facility: Ospedale Ca Foncello
state: Veneto
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: