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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Drug: Obinutuzumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obinutuzumab<br> | Drug: Obinutuzumab<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |