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This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First line |
| ||
| Relapsed/refractory |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | as prescribed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (Response rate, duration of response, progression-free survival) | 3 years | |
| Chronic lymphocytic leukaemia (CLL) Comorboid Scale | 3 years | |
| Quality-adjusted survival analysis (Q-TWIST methodology) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with B cell-lineage chronic lymphocytic leukaemia (B-CLL)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitoria-Gasteiz | Alava | 01009 | Spain | |||
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| rituximab [MabThera/Rituxan] |
| Drug |
as prescribed |
|
| 3 years |
| Alicante |
| Alicante |
| 03010 |
| Spain |
| Elche | Alicante | 03203 | Spain |
| Almería | Almeria | 04009 | Spain |
| Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Badalona | Barcelona | 08915 | Spain |
| Barcelona | Barcelona | 08025 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08907 | Spain |
| Sabadell | Barcelona | 08208 | Spain |
| Cadiz | Cadiz | 11009 | Spain |
| Jerez de la Frontera | Cadiz | 11407 | Spain |
| Puerto Real | Cadiz | 11510 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Castellon | Castellon | 12004 | Spain |
| Girona | Girona | 17007 | Spain |
| Huelva | Huelva | 21005 | Spain |
| Jaén | Jaen | 23007 | Spain |
| Ferrol | La Coruña | 15405 | Spain |
| Logroño | La Rioja | 26006 | Spain |
| Las Palmas | Las Palmas | 35020 | Spain |
| Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| León | Leon | 24071 | Spain |
| Lleida | Lerida | 25198 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28031 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Madrid | Madrid | 28905 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Málaga | Malaga | 29600 | Spain |
| Cartagena | Murcia | 30203 | Spain |
| Lorca | Murcia | 30800 | Spain |
| Pamplona | Navarre | 31008 | Spain |
| Gijón | Principality of Asturias | 33203 | Spain |
| Oviedo | Principality of Asturias | 33011 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Seville | Sevilla | 41014 | Spain |
| Tarragona | Tarragona | 43007 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Alzira | Valencia | 46600 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Valencia | Valencia | 46017 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Valladolid | Valladolid | 47010 | Spain |
| Bilbao | Vizcaya | 48013 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| 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 |
|---|---|
| D004358 | Drug Therapy |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| 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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