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This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MabThera/Rituxan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) | Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC. | Weeks 1, 5, 9, 12, 13, 17, 21 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment) | Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie | Innsbruck | 6020 | Austria | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab, Fludarabine, Cyclophosphamide | Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| fludarabine | Drug | Every 4 weeks, 6 cycles |
|
| cyclophosphamide | Drug | Every 4 weeks, 3 cycles |
|
| Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose) |
| Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment) | Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum. | Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose) |
| Time to Next Treatment - Percentage of Participants With an Event | Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment. | Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months |
| Time to Next Treatment - Time to Event | Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment. | Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months |
| Percentage of Participants With Adverse Events (AEs) | AEs were recorded from the date of first medication administration until 28 days after the last trial medication. | Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication. |
| LKH Hochsteiermark; Abt. für Innere Medizin |
| Leoben |
| 8700 |
| Austria |
| Kh Der Barmherzigen Schwestern; Interne I X | Linz | 4010 | Austria |
| A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt. | Linz | 4020 | Austria |
| Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung | Linz | 4020 | Austria |
| Landeskrankenhaus Rankweil; Interne E | Rankweil | 6830 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | 5020 | Austria |
| Klinikum Kreuzschwestern Wels; Iii. Interne Abt. | Wels | 4600 | Austria |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-To-Treat (ITT) population: all participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab, Fludarabine, Cyclophosphamide | Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) | Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 5, 9, 12, 13, 17, 21 and 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment) | Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment) | Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Next Treatment - Percentage of Participants With an Event | Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment. | Posted | Number | percentage of participants | Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Next Treatment - Time to Event | Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment. | Posted | Mean | Standard Deviation | days | Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | AEs were recorded from the date of first medication administration until 28 days after the last trial medication. | ITT population | Posted | Number | percentage of participants | Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication. |
|
|
Adverse events (AEs) were recorded from the date of first medication administration until 28 days after the last trial medication.
Number and percentage of subjects with at least one AE/SAE starting during study until within 28 days after the last trial medication by stem organ class and preferred term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab, Fludarabine, Cyclophosphamide | Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years). | 30 | 43 | 36 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Postoperative infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urninary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA 9.1 | Non-systematic Assessment |
| |
| Prostatic operation | Surgical and medical procedures | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Ateriogram coronary | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Fungal rash | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Omphalitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Postoperative infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dysphonia exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Burnout syndrome | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Convulsions local | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sensory loss | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vein pain | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
|
| NCI Clinical + Radiological (including CRu, CRi) |
|
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