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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04034056

Collaborator

(none)

300

Enrollment

Locations

63.9

Anticipated Duration (Months)

6.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma	Drug: Obinutuzumab

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.

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Sep 2, 2019

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Obinutuzumab	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).

Arm

Intervention/Treatment

Obinutuzumab

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).

Outcome Measures

Primary Outcome Measures

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]
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 Outcome Measures

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)]
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)]
Time to Next Treatment [From baseline to until end of the participant's observation period (up to approximately 65 months)]
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)]
Time from first dose to Loss of Clinical Benefit [From first dose to loss of clinical benefit, up to approx. 65 months]
Overall Response Rate [From baseline to until end of the participant's observation period (up to approximately 65 months)]
Complete Response (CR) [From baseline to until end of the participant's observation period (up to approximately 65 months)]
Complete Response at 30 months [From baseline to 30 months]
Time to Response [From first dose of Obinutuzumab to first documented response as assessed in clinical routine (up to approximately 65 months)]
Rate of Patients with Stable Disease [From baseline to until end of the participant's observation period (up to approximately 65 months)]
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]
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)]
Percentage of Participants with AEs of Special Interest (AESIs) [From baseline until end of the participant's observation period (up to approximately 65 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia	Pescara	Abruzzo	Italy	65100
2	Azienda Ospedaliera Bianchi-Melacrino-Morelli; Unità Operativa di Ematologia	Reggio Calabria	Calabria	Italy	89100
3	Azienda Ospedaliera S.G. Moscati; Divisione Ematologia	Avellino	Campania	Italy	83100
4	A.O. S. Anna e San Sebastiano	Caserta	Campania	Italy	81100
5	Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica	Napoli	Campania	Italy	80131
6	Ospedale Cardarelli; Divisione Di Ematologia	Napoli	Campania	Italy	80131
7	Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia	Pagani (Sa)	Campania	Italy	84016
8	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh	Bologna	Emilia-Romagna	Italy	40138
9	A.O. Universitaria Policlinico Di Modena; Ematologia	Modena	Emilia-Romagna	Italy	41124
10	Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia	Reggio Emilia	Emilia-Romagna	Italy	42100
11	Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica	Aviano	Friuli-Venezia Giulia	Italy	33081
12	Azienda Ospedaliero-Universitaria Santa Maria della Misericordia	Udine	Friuli-Venezia Giulia	Italy	33100
13	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma	Lazio	Italy	00133
14	Univesità La Sapienza Policlinico Umberto I	Roma	Lazio	Italy	00161
15	Policlinico Universitario Agostino Gemelli	Roma	Lazio	Italy	00168
16	Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien	Roma	Lazio	Italy	189
17	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)	Bergamo	Lombardia	Italy	24127
18	UOC Oncoematologia, Ospedale Maggiore Policlinico	Milano Policlinico Maggiore	Lombardia	Italy	20122
19	Irccs Ospedale San Raffaele	Milano	Lombardia	Italy	20132
20	Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia	Milano	Lombardia	Italy	20162
21	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia	Italy	27100
22	Ospedale Di Circolo E Fondazione Macchi; Ematologia	Varese	Lombardia	Italy	21100
23	Ospedali Riuniti Umberto I; Clinica di Ematologia	Ancona	Marche	Italy	60100
24	Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria	Alessandria	Piemonte	Italy	15121
25	Città della Salute e della Scienza di Torino. Presidio Molinette	Torino	Piemonte	Italy	10126
26	AOU Policlinico Consorziale;Ematologia	Bari	Puglia	Italy	70124
27	Giovanni Paolo II/I.R.C.C.S. Istituto Tumori	Bari	Puglia	Italy	70124
28	Asl Bat Ospedale Mons. Dimiccoli; U.O. Ematologia	Barletta	Puglia	Italy	75121
29	Ospedale Vito Fazzi	Lecce	Puglia	Italy	73100
30	Casa Sollievo della Sofferenza U.O. Ematologia	San Giovanni Rotondo (FG)	Puglia	Italy	71013
31	Az. Osp. C. Panico; Rep. Ematologia E Trapianto	Tricase - LE	Puglia	Italy	73039
32	Ospedale Businco; Ematologia	Cagliari	Sardegna	Italy	09121
33	Osp. San Francesco; Ematologia e CTMO	Nuoro	Sardegna	Italy	08100
34	ARNAS Garibaldi; Ematologia	Catania	Sicilia	Italy	95122
35	Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele	Catania	Sicilia	Italy	95123
36	Azienda Ospedaliera Vincenzo Cervello	Palermo	Sicilia	Italy	90127
37	Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo	Palermo	Sicilia	Italy	90146
38	Azienda Ospedaliera Universitaria Careggi	Florence	Toscana	Italy	50134
39	Azienda Ospedaliero Universitaria Pisana	Pisa	Toscana	Italy	56100
40	USL 4 di Prato - Nuovo Ospeale di Prato	Prato	Toscana	Italy	59100
41	A.O. Universitaria Senese; Ematologia	Siena	Toscana	Italy	53100
42	Azienda Ospedaliera S. Maria della Misericordia; Ematologia	Perugia	Umbria	Italy	06100
43	Az. Osp. S. Maria; Dept. Di Oncologia Medica	Terni	Umbria	Italy	05100
44	Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova	Padova	Veneto	Italy	35128
45	Ospedale Ca Foncello; Ematologia	Treviso	Veneto	Italy	31100
46	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma	Verona	Veneto	Italy	37134

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT04034056

Other Study ID Numbers:

ML41215

First Posted:

Jul 26, 2019

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Follicular

Obinutuzumab

Study Results

No Results Posted as of Jun 8, 2022