Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia (CLL-8)

This study has been completed.
Sponsor:
Collaborator:
German CLL Study Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00281918
First received: January 24, 2006
Last updated: September 9, 2013
Last verified: September 2013
Results First Received: December 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Rituximab
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fludarabine+Cyclophosphamide (FC) Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Participant Flow:   Overall Study
    Fludarabine+Cyclophosphamide (FC)     Fludarabine+Cyclophosphamide+Rituximab (FCR)  
STARTED     409 [1]   408 [2]
Safety Population; Received Study Drug     398     402  
COMPLETED     267 [3]   300 [3]
NOT COMPLETED     142     108  
[1] Informed consent unavailable for 2 patients at time of analysis; intent-to-treat population was 407.
[2] Informed consent unavailable for 5 patients at time of analysis; intent-to-treat population was 403.
[3] Completed all 6 cycles of study medication.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fludarabine+Cyclophosphamide (FC) Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
Total Total of all reporting groups

Baseline Measures
    Fludarabine+Cyclophosphamide (FC)     Fludarabine+Cyclophosphamide+Rituximab (FCR)     Total  
Number of Participants  
[units: participants]
  407     403     810  
Age  
[units: years]
Mean ± Standard Deviation
  59.3  ± 8.55     59.6  ± 8.70     59.5  ± 8.62  
Gender  
[units: participants]
     
Female     105     105     210  
Male     302     298     600  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Median observation time at time of analysis was approximately 21 months ]

2.  Primary:   Final Analysis: Time to Progression-free Survival Event   [ Time Frame: Median observation time was approximately 66.4 months ]

3.  Secondary:   Event-free Survival (EFS)   [ Time Frame: Median observation time at time of analysis was approximately 21 months ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Median observation time at time of analysis was approximately 21 months ]

5.  Secondary:   Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).   [ Time Frame: Median observation time at time of analysis was approximately 21 months ]

6.  Secondary:   Final Analysis: Time to Overall Survival Event   [ Time Frame: Median observation time was approximately 66.4 months ]

7.  Secondary:   Final Analysis: Time to Event-free Survival Event   [ Time Frame: Median observation time was approximately 66.4 months ]

8.  Secondary:   Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)   [ Time Frame: Median observation time was approximately 66.4 months ]

9.  Secondary:   Final Analysis: Duration of Response   [ Time Frame: Median observation time was approximately 66.4 months ]

10.  Secondary:   Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response   [ Time Frame: Median observation time was approximately 66.4 months ]

11.  Secondary:   Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)   [ Time Frame: Median observation time was approximately 66.4 months ]


  Serious Adverse Events
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Time Frame Adverse Events were recorded until 28 days after completion of study treatment (median time approximately 21 months). Serious Adverse Events reported until 1 year post-treatment or initiation of new CLL treatment (median time approximately 42 months).
Additional Description The safety population included all participants who received at least one dose of study drug.

Reporting Groups
  Description
Fludarabine+Cyclophosphamide (FC) Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Serious Adverse Events
    Fludarabine+Cyclophosphamide (FC)     Fludarabine+Cyclophosphamide+Rituximab (FCR)  
Total, serious adverse events      
# participants affected / at risk     164/398 (41.21%)     186/402 (46.27%)  
Blood and lymphatic system disorders      
Febrile Neutropenia † 1    
# participants affected / at risk     22/398 (5.53%)     31/402 (7.71%)  
Anaemia † 1    
# participants affected / at risk     10/398 (2.51%)     6/402 (1.49%)  
Leukopenia † 1    
# participants affected / at risk     3/398 (0.75%)     9/402 (2.24%)  
Neutropenia † 1    
# participants affected / at risk     3/398 (0.75%)     8/402 (1.99%)  
Thrombocytopenia † 1    
# participants affected / at risk     6/398 (1.51%)     6/402 (1.49%)  
Pancytopenia † 1    
# participants affected / at risk     3/398 (0.75%)     7/402 (1.74%)  
Haemolysis † 1    
# participants affected / at risk     3/398 (0.75%)     1/402 (0.25%)  
Febrile Bone Marrow Aplasia † 1    
# participants affected / at risk     0/398 (0.00%)     3/402 (0.75%)  
Granulocytopenia † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Haemolytic Anaemia † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Agranulocytosis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Bone Marrow Failure † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Coombs Positive Haemolytic Anaemia † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Evans Syndrome † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Haematotoxicity † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Lymphadenitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Splenomegaly † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Cardiac disorders      
Angina Pectoris † 1    
# participants affected / at risk     2/398 (0.50%)     5/402 (1.24%)  
Cardiac Failure † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Coronary Artery Disease † 1    
# participants affected / at risk     2/398 (0.50%)     0/402 (0.00%)  
Myocardial Infarction † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Myocardial Ischaemia † 1    
# participants affected / at risk     2/398 (0.50%)     0/402 (0.00%)  
Tachycardia † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Acute Myocardial Infarction † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Arrhythmia † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Cardiac Failure Congestive † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Cardiopulmonary Failure † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Sinus Bradycardia † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Supraventricular Extrasystoles † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Tachyarrhythmia † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Ventricular Fibrillation † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Ear and labyrinth disorders      
Vertigo † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Eye disorders      
Retinal Detachment † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Amaurosis Fugax † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Dacryostenosis Acquired † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Uveitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Vitreous Haemorrhage † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     2/398 (0.50%)     5/402 (1.24%)  
Vomiting † 1    
# participants affected / at risk     2/398 (0.50%)     3/402 (0.75%)  
Abdominal Pain † 1    
# participants affected / at risk     3/398 (0.75%)     1/402 (0.25%)  
Inguinal Hernia † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Abdominal Symptom † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Constipation † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Duodenal Ulcer Perforation † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Gastrointestinal Ulcer † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Haematemesis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Inguinal Hernia, Obstructive † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Nausea † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Pancreatitis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Tongue Ulceration † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     20/398 (5.03%)     18/402 (4.48%)  
Chest Pain † 1    
# participants affected / at risk     1/398 (0.25%)     3/402 (0.75%)  
Chills † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Adverse Drug Reaction † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Chest Discomfort † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Death † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
General Physical Health Deterioration † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
General Symptom † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Ill-Defined Disorder † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Mucosal Inflammation † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Multi-Organ Failure † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Pain † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Device occlusion † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Hepatobiliary disorders      
Cholelithiasis † 1    
# participants affected / at risk     2/398 (0.50%)     1/402 (0.25%)  
Cholecystitis † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Hepatitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Cholangitis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Cholecystitis Acute † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Hepatic Siderosis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Hepatotoxicity † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Drug-induced liver injury † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Immune system disorders      
Hypersensitivity † 1    
# participants affected / at risk     1/398 (0.25%)     3/402 (0.75%)  
Drug Hypersensitivity † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Anaphylactic Reaction † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Cytokine Release Syndrome † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     21/398 (5.28%)     18/402 (4.48%)  
Herpes Zoster † 1    
# participants affected / at risk     6/398 (1.51%)     8/402 (1.99%)  
Sepsis † 1    
# participants affected / at risk     8/398 (2.01%)     5/402 (1.24%)  
Bronchitis † 1    
# participants affected / at risk     5/398 (1.26%)     5/402 (1.24%)  
Infection † 1    
# participants affected / at risk     2/398 (0.50%)     5/402 (1.24%)  
Gastroenteritis † 1    
# participants affected / at risk     3/398 (0.75%)     2/402 (0.50%)  
Sinusitis † 1    
# participants affected / at risk     1/398 (0.25%)     4/402 (1.00%)  
Erysipelas † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Hepatitis B † 1    
# participants affected / at risk     2/398 (0.50%)     1/402 (0.25%)  
Pneumocystis Jiroveci Infection † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Pneumocystis Jiroveci Pneumonia † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Pneumonia Primary Atypical † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Viral Infection † 1    
# participants affected / at risk     0/398 (0.00%)     3/402 (0.75%)  
Cellulitis † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Cerebral Toxoplasmosis † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Diverticulitis † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Neutropenic Infection † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Oral Herpes † 1    
# participants affected / at risk     2/398 (0.50%)     0/402 (0.00%)  
Pneumonia Fungal † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Respiratory Tract Infection † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Abscess † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Appendicitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Bronchiolitis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Bronchopneumonia † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Chronic Sinusitis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Cytomegalovirus Infection † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Enterococcal Bacteraemia † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Gastroenteritis Cryptosporidial † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Hepatitis C † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Hepatobiliary Infection † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Herpes Simplex † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Herpes Virus Infection † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Herpes Zoster Ophthalmic † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Infected Skin Ulcer † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Lower Respiratory Tract Infection † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Lung Infection † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Lung Infection Pseudomonal † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Neutropenic Sepsis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Oesophageal Candidiasis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Orchitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Osteomyelitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Otitis Media † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Periorbital Cellulitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Pneumonia Respiratory Syncytial Viral † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Pseudomonal Sepsis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Septic Shock † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Skin Infection † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Staphylococcal Infection † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Subcutaneous Abscess † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Tonsillitis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Tuberculosis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Urosepsis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Device related infection † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Infectious pleural effusion † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Endophthalmitis † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Injury, poisoning and procedural complications      
Humerus Fracture † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Post Procedural Complication † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Investigations      
Catheterisation Cardiac † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Body Temperature Increased † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Metabolism and nutrition disorders      
Tumour Lysis Syndrome † 1    
# participants affected / at risk     2/398 (0.50%)     1/402 (0.25%)  
Dehydration † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Hyperuricaemia † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Gout † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Musculoskeletal and connective tissue disorders      
Intervertebral Disc Protrusion † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Kyphosis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Basal Cell Carcinoma † 1    
# participants affected / at risk     2/398 (0.50%)     1/402 (0.25%)  
Malignant Melanoma † 1    
# participants affected / at risk     2/398 (0.50%)     1/402 (0.25%)  
Prostate Cancer † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Acute Myeloid Leukaemia † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Lung Squamous Cell Carcinoma Stage Unspecified † 1    
# participants affected / at risk     2/398 (0.50%)     0/402 (0.00%)  
Adenocarcinoma † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Bladder Cancer † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Breast Cancer † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Central Nervous System Lymphoma † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Histiocytosis Haematophagic † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Hodgkin's Disease † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Lung Neoplasm Malignant † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Lymphoma † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Lymphoma Transformation † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Non-Small Cell Lung Cancer † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Pancreatic Carcinoma † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Pharyngeal Cancer Stage Unspecified † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Rectal Cancer † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Skin Cancer † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Squamous Cell Carcinoma † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Squamous Cell Carcinoma of Skin † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Transitional Cell Carcinoma † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Anogenital warts † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Nervous system disorders      
Syncope † 1    
# participants affected / at risk     2/398 (0.50%)     2/402 (0.50%)  
Headache † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Cerebrovascular Accident † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Convulsion † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Diabetic Neuropathy † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Encephalitis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Epilepsy † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Hemiparesis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Hydrocephalus † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Migraine † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Optic Neuritis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Stupor † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Transient Ischaemic Attack † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Cerebral Infarction † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Psychiatric disorders      
Completed Suicide † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Renal and urinary disorders      
Calculus Ureteric † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Cystitis Haemorrhagic † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Renal Failure † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Nephrolithiasis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Urinary Retention † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Urinary Tract Obstruction † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Renal Failure Acute † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Reproductive system and breast disorders      
Benign Prostatic Hyperplasia † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Pulmonary Embolism † 1    
# participants affected / at risk     2/398 (0.50%)     2/402 (0.50%)  
Dyspnoea † 1    
# participants affected / at risk     2/398 (0.50%)     1/402 (0.25%)  
Bronchospasm † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Dyspnoea Exertional † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Epistaxis † 1    
# participants affected / at risk     2/398 (0.50%)     1/402 (0.25%)  
Interstitial Lung Disease † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Lung Disorder † 1    
# participants affected / at risk     0/398 (0.00%)     2/402 (0.50%)  
Lung Infiltration † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Alveolitis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Alveolitis Allergic † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Chronic Obstructive Pulmonary Disease † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Chylothorax † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Dyspnoea at Rest † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Laryngeal Stenosis † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Pleural Effusion † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Respiration Abnormal † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Skin and subcutaneous tissue disorders      
Dermatitis Exfoliative † 1    
# participants affected / at risk     1/398 (0.25%)     1/402 (0.25%)  
Leukocytoclastic Vasculitis † 1    
# participants affected / at risk     2/398 (0.50%)     0/402 (0.00%)  
Urticaria † 1    
# participants affected / at risk     2/398 (0.50%)     0/402 (0.00%)  
Dermatitis Allergic † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Drug Eruption † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Erythema † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Pruritus † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Pustular Psoriasis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Rash † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Skin Ulcer † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Surgical and medical procedures      
Cholecystectomy † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Coronary Revascularisation † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Haemorrhoid Operation † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Prostatectomy † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Surgery † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Vascular disorders      
Hypotension † 1    
# participants affected / at risk     1/398 (0.25%)     2/402 (0.50%)  
Deep Vein Thrombosis † 1    
# participants affected / at risk     2/398 (0.50%)     0/402 (0.00%)  
Circulatory Collapse † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Thrombosis † 1    
# participants affected / at risk     1/398 (0.25%)     0/402 (0.00%)  
Vasculitis Necrotising † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Venous Thrombosis Limb † 1    
# participants affected / at risk     0/398 (0.00%)     1/402 (0.25%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (15.0)




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590


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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00281918     History of Changes
Other Study ID Numbers: CDR0000454560, GCLLSG-CLL-8, EU-20560, ML17102
Study First Received: January 24, 2006
Results First Received: December 21, 2009
Last Updated: September 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices