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Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Treatment in Chronic Lymphocytic Leukemia (CLL) | All participants receiving combination treatment in Chronic Lymphocytic Leukemia (CLL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Adverse Events (AEs) | From baseline to end of study up to 18 months | |
| Percentage of Serious Adverse Events (SAEs) | From baseline to end of study up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
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Previously untreated patients with Chronic Lymphocytic Leukemia (CLL)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belgrade | 11000 | Serbia | ||||
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| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Kragujevac |
| 34000 |
| Serbia |
| Novi Sad | 21000 | Serbia |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |