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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MabThera | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MabThera | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Baseline up to Year 6 |
| 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 |
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Inclusion Criteria:
Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg:
Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg:
- Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy
Exclusion Criteria:
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Participants receiving treatment for NHL or CLL with MabThera SC under observation according to standard of care and in line with the current local labelling in Korea.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | 420-767 | South Korea | |||
| Inje University Busan Paik Hospital |
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| Baseline up to Year 6 |
| Busan |
| 47392 |
| South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Daegu Catholic University Medical Center; Hematology | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | 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 |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Inje University, Sanggye-Paik Hospital | Seoul | 01757 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Seoul National University Hospital; Department of Oncology | Seoul | 110-744 | South Korea |
| Severance Hospital, Yonsei University Health System; Oncology | Seoul | 120-752 | South Korea |
| Samsung Medical Centre; Division of Hematology/Oncology | Seoul | 135-710 | South Korea |
| St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine | Seoul | 137-701 | South Korea |
| Korea Cancer Center Hospital; Surgery | Seoul | 139-709 | South Korea |
| Korea University Guro Hospital; Department of Hematology & Oncology | Seoul | 152-703 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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