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

March 12, 2024 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Abruzzo
      • Pescara, Abruzzo, Italy, 65100
        • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89100
        • Azienda Ospedaliera Bianchi-Melacrino-Morelli; Unità Operativa di Ematologia
    • Campania
      • Avellino, Campania, Italy, 83100
        • Azienda Ospedaliera S.G. Moscati; Divisione Ematologia
      • Caserta, Campania, Italy, 81100
        • A.O. S. Anna e San Sebastiano
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
      • Napoli, Campania, Italy, 80131
        • Ospedale Cardarelli; Divisione Di Ematologia
      • Pagani (Sa), Campania, Italy, 84016
        • Ospedale "A.Tortora" ? Ematologia; Dipartimento Di Ematologia
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
      • Modena, Emilia-Romagna, Italy, 41124
        • A.O. Universitaria Policlinico Di Modena; Ematologia
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Lazio, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
      • Roma, Lazio, Italy, 189
        • Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
      • Roma, Lazio, Italy, 00161
        • Univesità La Sapienza Policlinico Umberto I
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
      • Milano, Lombardia, Italy, 20162
        • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
      • Milano, Lombardia, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano Policlinico Maggiore, Lombardia, Italy, 20122
        • UOC Oncoematologia, Ospedale Maggiore Policlinico
      • Pavia, Lombardia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Varese, Lombardia, Italy, 21100
        • Ospedale Di Circolo E Fondazione Macchi; Ematologia
    • Marche
      • Ancona, Marche, Italy, 60100
        • Ospedali Riuniti Umberto I; Clinica di Ematologia
    • Piemonte
      • Alessandria, Piemonte, Italy, 15121
        • Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
      • Torino, Piemonte, Italy, 10126
        • Città della Salute e della Scienza di Torino. Presidio Molinette
    • Puglia
      • Bari, Puglia, Italy, 70124
        • AOU Policlinico Consorziale;Ematologia
      • Bari, Puglia, Italy, 70124
        • Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
      • Barletta, Puglia, Italy, 75121
        • Asl Bat Ospedale Mons. Dimiccoli; U.O. Ematologia
      • Lecce, Puglia, Italy, 73100
        • Ospedale Vito Fazzi
      • San Giovanni Rotondo (FG), Puglia, Italy, 71013
        • Casa Sollievo della Sofferenza U.O. Ematologia
      • Tricase - LE, Puglia, Italy, 73039
        • Az. Osp. C. Panico; Rep. Ematologia E Trapianto
    • Sardegna
      • Cagliari, Sardegna, Italy, 09121
        • Ospedale Businco; Ematologia
      • Nuoro, Sardegna, Italy, 08100
        • Osp. San Francesco; Ematologia e CTMO
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
      • Catania, Sicilia, Italy, 95122
        • ARNAS Garibaldi; Ematologia
      • Palermo, Sicilia, Italy, 90127
        • Azienda Ospedaliera Vincenzo Cervello
      • Palermo, Sicilia, Italy, 90146
        • Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo
    • Toscana
      • Florence, Toscana, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Pisa, Toscana, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Prato, Toscana, Italy, 59100
        • USL 4 di Prato - Nuovo Ospeale di Prato
      • Siena, Toscana, Italy, 53100
        • A.O. Universitaria Senese; Ematologia
    • Umbria
      • Perugia, Umbria, Italy, 06100
        • Azienda Ospedaliera S. Maria della Misericordia; Ematologia
      • Terni, Umbria, Italy, 05100
        • Az. Osp. S. Maria; Dept. Di Oncologia Medica
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
      • Treviso, Veneto, Italy, 31100
        • Ospedale Ca Foncello; Ematologia
      • Verona, Veneto, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of Disease at 2 Years
Time Frame: 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
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
Time Frame: 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
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

Outcome Measure
Time Frame
Progression Free Survival (PFS) at 2 years
Time Frame: From baseline to until end of the participant's observation period or death from any cause, whichever occurs first (up to approximately 24 months)
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
Time Frame: From baseline to until end of the participant's observation period or death from any cause, whichever occurs first (up to approximately 36 months)
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
Time Frame: From baseline to until end of the participant's observation period (up to approximately 65 months)
From baseline to until end of the participant's observation period (up to approximately 65 months)
Overall Survival
Time Frame: From baseline to until end of the participant's observation period or death from any cause, whichever occurs first (up to approximately 65 months)
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
Time Frame: From first dose to loss of clinical benefit, up to approx. 65 months
From first dose to loss of clinical benefit, up to approx. 65 months
Overall Response Rate
Time Frame: From baseline to until end of the participant's observation period (up to approximately 65 months)
From baseline to until end of the participant's observation period (up to approximately 65 months)
Complete Response (CR)
Time Frame: From baseline to until end of the participant's observation period (up to approximately 65 months)
From baseline to until end of the participant's observation period (up to approximately 65 months)
Complete Response at 30 months
Time Frame: From baseline to 30 months
From baseline to 30 months
Time to Response
Time Frame: From first dose of Obinutuzumab to first documented response as assessed in clinical routine (up to approximately 65 months)
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
Time Frame: From baseline to until end of the participant's observation period (up to approximately 65 months)
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
Time Frame: From baseline until end of the participant's observation period (up to approximately 65 months
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
Time Frame: From baseline to until end of the participant's observation period (up to approximately 65 months)
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)
Time Frame: From baseline until end of the participant's observation period (up to approximately 65 months)
From baseline until end of the participant's observation period (up to approximately 65 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Estimated)

April 22, 2024

Study Completion (Estimated)

April 22, 2024

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML41215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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