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This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [Mabthera/Rituxan] | Drug | As prescribed by physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| infusion-related adverse events | data collection every 4-6 weeks for up to 6 months for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| usage and applicability of 90-minute iv infusion in patients with CLL | data collection every 4-6 weeks for up to 6 months for each patient |
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Inclusion Criteria:
Exclusion Criteria:
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CLL patients receiving standard of care rituximab infusions at haematological or medical clinics
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gävle | 80187 | Sweden | ||||
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| Gothenburg |
| SE-41 343 |
| Sweden |
| Huddinge | 14186 | Sweden |
| Jönköping | 551_85 | Sweden |
| Kalmar | 39185 | Sweden |
| Karlstad | 65185 | Sweden |
| Kristianstad | 29185 | Sweden |
| Lidköping | S-53131 | Sweden |
| Linköping | 581 85 | Sweden |
| Luleå | S-971 80 | Sweden |
| Mora | S-79285 | Sweden |
| Norrköping | 60182 | Sweden |
| Oskarshamn | 57251 | Sweden |
| Stockholm | 17176 | Sweden |
| Sundsvall | 85186 | Sweden |
| Umeå | 901 85 | Sweden |
| Västervik | 59381 | Sweden |
| Visby | 62184 | Sweden |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| 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 |
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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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