Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)

Follicular Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04034056
• Other study ID #: ML41215
• Status: Active, not recruiting
• Start date: September 2, 2019
• Est. completion date: April 22, 2024

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 299
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria	Alessandria	Piemonte
Italy	Ospedali Riuniti Umberto I; Clinica di Ematologia	Ancona	Marche
Italy	Azienda Ospedaliera S.G. Moscati; Divisione Ematologia	Avellino	Campania
Italy	Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica	Aviano	Friuli-Venezia Giulia
Italy	AOU Policlinico Consorziale;Ematologia	Bari	Puglia
Italy	Giovanni Paolo II/I.R.C.C.S. Istituto Tumori	Bari	Puglia
Italy	Asl Bat Ospedale Mons. Dimiccoli; U.O. Ematologia	Barletta	Puglia
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)	Bergamo	Lombardia
Italy	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh	Bologna	Emilia-Romagna
Italy	Ospedale Businco; Ematologia	Cagliari	Sardegna
Italy	A.O. S. Anna e San Sebastiano	Caserta	Campania
Italy	ARNAS Garibaldi; Ematologia	Catania	Sicilia
Italy	Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele	Catania	Sicilia
Italy	Azienda Ospedaliera Universitaria Careggi	Florence	Toscana
Italy	Ospedale Vito Fazzi	Lecce	Puglia
Italy	Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia	Milano	Lombardia
Italy	Irccs Ospedale San Raffaele	Milano	Lombardia
Italy	UOC Oncoematologia, Ospedale Maggiore Policlinico	Milano Policlinico Maggiore	Lombardia
Italy	A.O. Universitaria Policlinico Di Modena; Ematologia	Modena	Emilia-Romagna
Italy	Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica	Napoli	Campania
Italy	Ospedale Cardarelli; Divisione Di Ematologia	Napoli	Campania
Italy	Osp. San Francesco; Ematologia e CTMO	Nuoro	Sardegna
Italy	Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova	Padova	Veneto
Italy	Ospedale "A.Tortora" ? Ematologia; Dipartimento Di Ematologia	Pagani (Sa)	Campania
Italy	Azienda Ospedaliera Vincenzo Cervello	Palermo	Sicilia
Italy	Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo	Palermo	Sicilia
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia
Italy	Azienda Ospedaliera S. Maria della Misericordia; Ematologia	Perugia	Umbria
Italy	Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia	Pescara	Abruzzo
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	Toscana
Italy	USL 4 di Prato - Nuovo Ospeale di Prato	Prato	Toscana
Italy	Azienda Ospedaliera Bianchi-Melacrino-Morelli; Unità Operativa di Ematologia	Reggio Calabria	Calabria
Italy	Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia	Reggio Emilia	Emilia-Romagna
Italy	Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien	Roma	Lazio
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma	Lazio
Italy	Policlinico Universitario Agostino Gemelli	Roma	Lazio
Italy	Univesità La Sapienza Policlinico Umberto I	Roma	Lazio
Italy	Casa Sollievo della Sofferenza U.O. Ematologia	San Giovanni Rotondo (FG)	Puglia
Italy	A.O. Universitaria Senese; Ematologia	Siena	Toscana
Italy	Az. Osp. S. Maria; Dept. Di Oncologia Medica	Terni	Umbria
Italy	Città della Salute e della Scienza di Torino. Presidio Molinette	Torino	Piemonte
Italy	Ospedale Ca Foncello; Ematologia	Treviso	Veneto
Italy	Az. Osp. C. Panico; Rep. Ematologia E Trapianto	Tricase - LE	Puglia
Italy	Azienda Ospedaliero-Universitaria Santa Maria della Misericordia	Udine	Friuli-Venezia Giulia
Italy	Ospedale Di Circolo E Fondazione Macchi; Ematologia	Varese	Lombardia
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma	Verona	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of Disease at 2 Years		Treatment initiation with obinutuzumab until first documented progression of disease or death due to disease progression, whichever occurs first, within 24 months from start of treatment
Primary	Duration of Response		From first documentation of CR or partial response (PR) (whichever occurs first) until disease progression, as evaluated by the physician according to routine clinical practice or death, up to approximately 65 months
Secondary	Progression Free Survival (PFS) at 2 years		From baseline to until end of the participant's observation period or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary	PFS at 3 years		From baseline to until end of the participant's observation period or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary	Time to Next Treatment		From baseline to until end of the participant's observation period (up to approximately 65 months)
Secondary	Overall Survival		From baseline to until end of the participant's observation period or death from any cause, whichever occurs first (up to approximately 65 months)
Secondary	Time from first dose to Loss of Clinical Benefit		From first dose to loss of clinical benefit, up to approx. 65 months
Secondary	Overall Response Rate		From baseline to until end of the participant's observation period (up to approximately 65 months)
Secondary	Complete Response (CR)		From baseline to until end of the participant's observation period (up to approximately 65 months)
Secondary	Complete Response at 30 months		From baseline to 30 months
Secondary	Time to Response		From first dose of Obinutuzumab to first documented response as assessed in clinical routine (up to approximately 65 months)
Secondary	Rate of Patients with Stable Disease		From baseline to until end of the participant's observation period (up to approximately 65 months)
Secondary	18F-fluorodeoxyglucose Positron Emission Tomography Response at End of Induction and End of Maintenance		From baseline until end of the participant's observation period (up to approximately 65 months
Secondary	Percentage of Participants with Adverse Events (AE) and Serious AE		From baseline to until end of the participant's observation period (up to approximately 65 months)
Secondary	Percentage of Participants with AEs of Special Interest (AESIs)		From baseline until end of the participant's observation period (up to approximately 65 months)