HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00349349
First received: July 6, 2006
Last updated: June 27, 2013
Last verified: June 2013
Results First Received: October 20, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukaemia, Lymphocytic, Chronic
Intervention: Drug: ofatumumab

  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
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Reporting Groups
  Description
2000 mg Ofatumumab + DR Ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The independent endpoint review committee (IRC) classified these participants as double refractory (DR), defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
2000 mg Ofatumumab + BFR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
2000 mg Ofatumumab + Other Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR.

Participant Flow:   Overall Study
    2000 mg Ofatumumab + DR     2000 mg Ofatumumab + BFR     2000 mg Ofatumumab + Other  
STARTED     95     112     16  
COMPLETED     42     50     10  
NOT COMPLETED     53     62     6  
Adverse Event                 5                 6                 2  
Withdrawal by Subject                 5                 2                 1  
Withdrawn due to Disease Progression                 27                 37                 1  
Death                 13                 10                 1  
Other Treatment Selected                 2                 0                 0  
Participant Reduced General Condition                 0                 1                 0  
Physician Decision                 1                 2                 1  
No Response                 0                 3                 0  
New Malignancy (Bladder Cancer)                 0                 1                 0  



  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
2000 mg Ofatumumab + DR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
2000 mg Ofatumumab + BFR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
2000 mg Ofatumumab + Other Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as "other,"defined as participants who were enrolled in the study but did not meet criteria for DR or BFR.
Total Total of all reporting groups

Baseline Measures
    2000 mg Ofatumumab + DR     2000 mg Ofatumumab + BFR     2000 mg Ofatumumab + Other     Total  
Number of Participants  
[units: participants]
  95     112     16     223  
Age  
[units: Years]
Mean ± Standard Deviation
  63.2  ± 8.4     64.4  ± 9.3     64.5  ± 7.4     63.9  ± 8.8  
Gender  
[units: Participants]
       
Female     24     31     5     60  
Male     71     81     11     163  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     1     0     1     2  
Black or African American     2     1     0     3  
Hispanic or Latino     1     0     0     1  
White     88     111     15     214  
Arab     1     0     0     1  
Yemenite     1     0     0     1  
Middle Eastern     1     0     0     1  



  Outcome Measures
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1.  Primary:   Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines   [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 24 ]

2.  Secondary:   Duration of Response   [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 24 ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 24 ]

4.  Secondary:   Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment   [ Time Frame: Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months]) ]

5.  Secondary:   Overall Survival   [ Time Frame: Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks) ]

6.  Secondary:   Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts   [ Time Frame: Baseline (Visit 2) until Week 7 (Visit 9) ]

7.  Secondary:   Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts   [ Time Frame: Baseline (Visit 2) until Week 7 (Visit 9) ]

8.  Secondary:   Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)   [ Time Frame: Baseline (Visit 2) until Week 24 (Visit 14) ]

9.  Secondary:   Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24   [ Time Frame: Baseline (Visit 2) and Week 24 ]

10.  Secondary:   Number of Participants With Complete Resolution of Lymphadenopathy   [ Time Frame: Baseline (Visit 2) to end of study (up to Week 24) ]

11.  Secondary:   Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24   [ Time Frame: Baseline (Visit 2) and Week 24 ]

12.  Secondary:   Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening   [ Time Frame: Screening (Visit 1, <=14 days prior to Visit 2) ]

13.  Secondary:   Number of Participants With Improvement in Hemoglobin   [ Time Frame: Baseline (Visit 2) to Week 28 ]

14.  Secondary:   Number of Participants With Improvement in Thrombocytopenia (Thromb.)   [ Time Frame: Baseline (Visit 2) to Week 28 ]

15.  Secondary:   Number of Participants With Complete Resolution of Hepatomegaly   [ Time Frame: Baseline (Visit 2) until Week 24 ]

16.  Secondary:   Number of Participants With Improvement in Neutropenia   [ Time Frame: Baseline (Visit 2) to Week 28 ]

17.  Secondary:   Number of Participants With Complete Resolution of Splenomegaly   [ Time Frame: Baseline (Visit 2) until Week 24 ]

18.  Secondary:   Number of Participants Who Experienced Any Adverse Event   [ Time Frame: From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up) ]

19.  Secondary:   Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24) ]

20.  Secondary:   AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit 14 (Week 24) ]

21.  Secondary:   Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit14 (Week 24) ]

22.  Secondary:   Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit 14 (Week 24) ]

23.  Secondary:   Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit 14 (Week 24) ]


  Serious Adverse Events
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Additional Description No text entered.

Reporting Groups
  Description
2000 mg Ofatumumab + DR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
2000 mg Ofatumumab + BFR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
2000 mg Ofatumumab + Other Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as "other,"defined as participants who were enrolled in the study but did not meet criteria for DR or BFR.

Serious Adverse Events
    2000 mg Ofatumumab + DR     2000 mg Ofatumumab + BFR     2000 mg Ofatumumab + Other  
Total, serious adverse events        
# participants affected / at risk     60/95 (63.16%)     59/112 (52.68%)     12/16 (75.00%)  
Blood and lymphatic system disorders        
Neutropenia † 1      
# participants affected / at risk     7/95 (7.37%)     3/112 (2.68%)     3/16 (18.75%)  
Febrile neutropenia † 1      
# participants affected / at risk     2/95 (2.11%)     3/112 (2.68%)     1/16 (6.25%)  
Hemolytic anaemia † 1      
# participants affected / at risk     0/95 (0.00%)     2/112 (1.79%)     0/16 (0.00%)  
Agranulocytosis † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Anemia † 1      
# participants affected / at risk     2/95 (2.11%)     1/112 (0.89%)     0/16 (0.00%)  
Anemia haemolytic autoimmune † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Lymphocytic infiltration † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Thrombocytopenia † 1      
# participants affected / at risk     4/95 (4.21%)     1/112 (0.89%)     0/16 (0.00%)  
Cardiac disorders        
Myocardial infarction † 1      
# participants affected / at risk     1/95 (1.05%)     2/112 (1.79%)     0/16 (0.00%)  
Myocardial ischaemia † 1      
# participants affected / at risk     0/95 (0.00%)     2/112 (1.79%)     0/16 (0.00%)  
Cardic failure † 1      
# participants affected / at risk     1/95 (1.05%)     1/112 (0.89%)     0/16 (0.00%)  
Myopericarditis † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Cardiac arrest † 1      
# participants affected / at risk     0/95 (0.00%)     2/112 (1.79%)     0/16 (0.00%)  
Ear and labyrinth disorders        
Vertigo † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Eye disorders        
Diplopia † 1      
# participants affected / at risk     1/95 (1.05%)     1/112 (0.89%)     0/16 (0.00%)  
Gastrointestinal disorders        
Small intestinal obstruction † 1      
# participants affected / at risk     1/95 (1.05%)     1/112 (0.89%)     0/16 (0.00%)  
Enteritis † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Ascites † 1      
# participants affected / at risk     1/95 (1.05%)     1/112 (0.89%)     0/16 (0.00%)  
Abdominal pain † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Constipation † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Diarrhea † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Gastrointestinal pain † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
General disorders        
Disease progression † 1      
# participants affected / at risk     4/95 (4.21%)     5/112 (4.46%)     1/16 (6.25%)  
Pyrexia † 1      
# participants affected / at risk     6/95 (6.32%)     4/112 (3.57%)     0/16 (0.00%)  
Hyperthermia † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Infusion related reaction † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Immune system disorders        
Cytokine release syndrome † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Hypersensitivity † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Contrast media allergy † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Immunodeficiency † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Infections and infestations        
Pneumonia † 1      
# participants affected / at risk     12/95 (12.63%)     12/112 (10.71%)     2/16 (12.50%)  
Sepsis † 1      
# participants affected / at risk     5/95 (5.26%)     6/112 (5.36%)     0/16 (0.00%)  
Bronchopneumonia † 1      
# participants affected / at risk     2/95 (2.11%)     1/112 (0.89%)     0/16 (0.00%)  
Herpes zoster † 1      
# participants affected / at risk     2/95 (2.11%)     1/112 (0.89%)     0/16 (0.00%)  
Neutropenic sepsis † 1      
# participants affected / at risk     4/95 (4.21%)     0/112 (0.00%)     1/16 (6.25%)  
Sinusitis † 1      
# participants affected / at risk     2/95 (2.11%)     2/112 (1.79%)     0/16 (0.00%)  
Urinary tract infection † 1      
# participants affected / at risk     2/95 (2.11%)     2/112 (1.79%)     0/16 (0.00%)  
Bronchitis † 1      
# participants affected / at risk     2/95 (2.11%)     0/112 (0.00%)     0/16 (0.00%)  
Septic shock † 1      
# participants affected / at risk     3/95 (3.16%)     0/112 (0.00%)     0/16 (0.00%)  
Lobar pneumonia † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Appendicitis † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Aspergilloma † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Cellulitis † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Enterocolitis infection † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Folliculitis † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Fusarium infection † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Gastroenteritis † 1      
# participants affected / at risk     1/95 (1.05%)     1/112 (0.89%)     0/16 (0.00%)  
Infection † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Injection site infection † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Lung infection † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Peritoneal infection † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Pneumocystis jiroveci pneumonia † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Pneumonia fungal † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Progessive multifocal † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Pseudomonas infection † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Upper respiratory tract infection † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Lower respiration infection † 1      
# participants affected / at risk     0/95 (0.00%)     2/112 (1.79%)     0/16 (0.00%)  
Ear infection † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Eczema infected † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Erysipelas † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Enterocolitis infections † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Escherichia sepsis † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Eye infection staphylococcal † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Influenza † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Nocardiosis † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Pseuromonas infection † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Respiratory tract infection † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Injury, poisoning and procedural complications        
Fall † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Accidental overdose † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Postoperative fever † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Transfusion reaction † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Lower limb fracture † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Spinal compression fracture † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Investigations        
Blood lactate dehydrogenase increased † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Neutrophil count decreased † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Blood uric acid increased † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Metabolism and nutrition disorders        
Diabetes mellitus inadequate control † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Hypercalcaemia † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Diabetes † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Hypokalemia † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Musculoskeletal and connective tissue disorders        
Back pain † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Arthralgia † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Bone pain † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Breast cancer † 1      
# participants affected / at risk     1/95 (1.05%)     1/112 (0.89%)     0/16 (0.00%)  
Chronic lympocytic leukaemia † 1      
# participants affected / at risk     1/95 (1.05%)     3/112 (2.68%)     0/16 (0.00%)  
Hodgkins disease † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Mantle cell lymphoma † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Chronic lymphocytic leukaemia transformation † 1      
# participants affected / at risk     2/95 (2.11%)     0/112 (0.00%)     0/16 (0.00%)  
Bladder cancer † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Bowen's disease † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Colon cancer † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Neoplasm † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Skin cancer † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Squamous cell carcinoma of the skin † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Tumor lysis syndrome † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Nervous system disorders        
Facial paresis † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Hemiparesis † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Ischaemic stroke † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Transient ischaemic attack † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Cerebral ischemia † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Epilepsy † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Psychiatric disorders        
Confusional state † 1      
# participants affected / at risk     2/95 (2.11%)     0/112 (0.00%)     0/16 (0.00%)  
Renal and urinary disorders        
Urinary retention † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Haemoptysis † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Hypoxia † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Pleural effusion † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     1/16 (6.25%)  
Pulmonary embolism † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Pulmonary edema † 1      
# participants affected / at risk     0/95 (0.00%)     2/112 (1.79%)     0/16 (0.00%)  
Acute repiratory failure † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Bronchospasm † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Dyspnea † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Lung disorder † 1      
# participants affected / at risk     0/95 (0.00%)     1/112 (0.89%)     0/16 (0.00%)  
Lung infiltration † 1      
# participants affected / at risk     0/95 (0.00%)     0/112 (0.00%)     1/16 (6.25%)  
Respiratory failure † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Skin and subcutaneous tissue disorders        
Pyroderma gangrenosum † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Rash † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Vascular disorders        
Deep vein thrombosis † 1      
# participants affected / at risk     1/95 (1.05%)     2/112 (1.79%)     0/16 (0.00%)  
Haematoma † 1      
# participants affected / at risk     1/95 (1.05%)     0/112 (0.00%)     0/16 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00349349     History of Changes
Other Study ID Numbers: 111773, Hx-CD20-406
Study First Received: July 6, 2006
Results First Received: October 20, 2011
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration