An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)

Study Overview
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Brief Summary
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This is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.

Official Title
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Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Conditions
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Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell

Intervention / Treatment
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* Drug: MabThera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants administered with MabThera subcutaneously within the approved indication in Korea Participants previously untreated with MabThera subcutaneously Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg: Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants Previously untreated FL participants in combination with chemotherapy Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy. Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg: - Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy Exclusion Criteria: Pregnant or breastfeeding women Participants who are out of locally approved indications, dosage, and administration including medication error Contraindication in use by locally approved indications, dosage, and administration

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| MabThera<br>Participants with NHL will be administered 1400 milligrams (mg) and those with with CLL will be administered 1600 mg MabThera subcutaneously at the discretion of the physician in accordance with local clinical practice and local labeling, and will be observed for 6 years. | Drug: MabThera<br>* Participants will be administered MabThera 1400 mg (NHL) or 1600 mg (CLL) at the discretion of the physician in accordance with local clinical practice and local labeling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events |  | Baseline up to Year 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL |  | Baseline up to Year 6 | 
| Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria |  | Baseline up to Year 6 |