Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization. The study population comprises patients with approved local indications chronic lymphocytic leukemia (CLL) and/or follicular lymphoma (FL) in routine clinical practice after launch.

Official Title
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Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients

Conditions
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Follicular Lymphoma, Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Biological: obinutuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Administered obinutuzumab under the approved indications in Korea at investigator's discretion Previously untreated with obinutuzumab Exclusion Criteria: Out-of locally approved indications, dosage, and administration Pregnant women, breastfeeding women Hepatic disease Participate in other clinical trials

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>Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab. | Biological: obinutuzumab<br>* Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.<br>* Other names: Gazyva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR) |  | from baseline until the end of the participant's observation period (up to approximately 8 years) | 
| Percentage of Participants with Unexpected AE/ADR |  | from baseline until end of the participant's observation period (up to approximately 8 years) | 
| Percentage of Participants with Expected ADR |  | from baseline until end of the participant's observation period (up to approximately 8 years) | 
| Percentage of Participants with Non-serious ADR |  | from baseline until end of the participant's observation period (up to approximately 8 years) | 
| Percentage of Participants with AEs of Special Interest (AESIs) |  | from baseline until end of the participant's observation period (up to approximately 8 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for CLL or Cheson 2014 criteria for FL | from baseline until end of the participant's observation period (up to approximately 8 years) | 
| Stable Disease Rate | According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL | from baseline until end of the participant's observation period (up to approximately 8 years) | 
| Progressive Disease Rate | According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL | from baseline until end of the participant's observation period (up to approximately 8 years) |