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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obinutuzumab | Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| obinutuzumab | Biological | Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants, who are going to receive obinutuzumab for one or more administrations according to medical opinions of the investigator in charge of surveillance, will be registered for this surveillance and treated with obinutuzumab under the approval conditions of the product in Korea
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital; Hematology-oncology | Busan | 47392 | South Korea | |||
| Pusan National University Hospital |
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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) |
| Busan |
| 602-739 |
| South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Hallym University Sacred Heart Hospital; Department of Hematology | Gyeonggi-do | 431-070 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology | Incheon | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| ChungAng University Hospital | Seoul | 06973 | South Korea |
| Borame Medical Center | Seoul | 07061 | South Korea |
| Yeouido St. Mary's Hospital | Seoul | 07345 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | 6591 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 220-701 | South Korea |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
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