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Trial record 13 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00096044
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: rituximab
Drug: lenalidomide
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Period Title: Overall Study
Started 45
Completed 11
Not Completed 34
Reason Not Completed
Withdrawal by Subject             9
Adverse Event             21
Disease Progression             4
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
64.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
9
  20.0%
Male
36
  80.0%
1.Primary Outcome
Title Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months
Hide Description Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
Time Frame at 6 Months
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All treated and eligible patients
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.9
(53.4 to 81.8)
2.Secondary Outcome
Title Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab
Hide Description Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
Time Frame 5 years
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Hide Analysis Population Description
All treated with combination therapy of CC-5013+Rituximab and eligible patients
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Overall Number of Participants Analyzed 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(63.1 to 100)
3.Secondary Outcome
Title Number of Participants With Adverse Events on Single Agent CC-5013
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Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0

Please refer to the adverse event reporting for more detail.

Time Frame 1 year
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All treated and eligible patients
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
0
   0.0%
Grade 2
3
   6.7%
Grade 3
7
  15.6%
Grade 4
33
  73.3%
Grade 5
2
   4.4%
4.Secondary Outcome
Title Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab
Hide Description Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0
Time Frame Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated with combination therapy of CC-5013+Rituximab and eligible patients
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
1
  12.5%
Grade 2
0
   0.0%
Grade 3
3
  37.5%
Grade 4
3
  37.5%
5.Secondary Outcome
Title Time to Progression for Single Agent CC-5013
Hide Description Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
Time Frame 5 years
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Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: months
23.0
(12.1 to 78.7)
6.Secondary Outcome
Title Time to Progression for the Combination Therapy of CC-5013+Rituximab
Hide Description Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
Time Frame Every month up to 6 months and every 3 months thereafter up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated with combination therapy of CC-5013+Rituximab and eligible patients
Arm/Group Title Oral Lenalidomide
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Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: months
18.7
(0.9 to 23.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Lenalidomide
Hide Arm/Group Description

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

rituximab: IV

lenalidomide: Oral

All-Cause Mortality
Oral Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Lenalidomide
Affected / at Risk (%) # Events
Total   29/45 (64.44%)    
Blood and lymphatic system disorders   
Anaemia   4/45 (8.89%)  5
Febrile neutropenia   11/45 (24.44%)  16
Neutropenia   5/45 (11.11%)  6
Thrombocytopenia   4/45 (8.89%)  4
Cardiac disorders   
Cardio-respiratory arrest   2/45 (4.44%)  2
Myocardial ischaemia   1/45 (2.22%)  1
Palpitations   1/45 (2.22%)  1
Gastrointestinal disorders   
Diarrhoea   1/45 (2.22%)  1
Nausea   1/45 (2.22%)  1
General disorders   
Chest pain   3/45 (6.67%)  3
Chills   1/45 (2.22%)  1
Death   2/45 (4.44%)  2
Fatigue   1/45 (2.22%)  1
Pyrexia   3/45 (6.67%)  3
Hepatobiliary disorders   
Hyperbilirubinaemia   1/45 (2.22%)  1
Infections and infestations   
Bacteraemia   1/45 (2.22%)  1
Device related infection   1/45 (2.22%)  1
Diverticulitis   1/45 (2.22%)  1
Herpes simplex   1/45 (2.22%)  1
Herpes zoster   1/45 (2.22%)  1
Infection   2/45 (4.44%)  3
Lobar pneumonia   1/45 (2.22%)  1
Pneumonia   12/45 (26.67%)  15
Pseudomonal bacteraemia   1/45 (2.22%)  1
Sepsis   2/45 (4.44%)  2
Sinusitis   1/45 (2.22%)  1
Skin infection   1/45 (2.22%)  1
Staphylococcal infection   1/45 (2.22%)  1
Upper respiratory tract infection   2/45 (4.44%)  2
Injury, poisoning and procedural complications   
Collapse of lung   1/45 (2.22%)  1
Investigations   
Breath sounds abnormal   1/45 (2.22%)  1
Metabolism and nutrition disorders   
Hypercalcaemia   1/45 (2.22%)  1
Hypocalcaemia   1/45 (2.22%)  1
Hyponatraemia   1/45 (2.22%)  1
Tumour lysis syndrome   1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia   1/45 (2.22%)  1
Back pain   1/45 (2.22%)  1
Bone pain   1/45 (2.22%)  1
Musculoskeletal discomfort   1/45 (2.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare   3/45 (6.67%)  3
Psychiatric disorders   
Confusional state   1/45 (2.22%)  1
Mental status changes   1/45 (2.22%)  1
Renal and urinary disorders   
Renal failure   1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis   1/45 (2.22%)  1
Cough   1/45 (2.22%)  1
Dyspnoea   3/45 (6.67%)  4
Hypoxia   1/45 (2.22%)  1
Laryngospasm   1/45 (2.22%)  1
Pleural effusion   3/45 (6.67%)  5
Pneumonitis   1/45 (2.22%)  1
Pulmonary embolism   3/45 (6.67%)  3
Skin and subcutaneous tissue disorders   
Hyperhidrosis   1/45 (2.22%)  1
Surgical and medical procedures   
Intestinal anastomosis   1/45 (2.22%)  1
Vascular disorders   
Deep vein thrombosis   2/45 (4.44%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Lenalidomide
Affected / at Risk (%) # Events
Total   44/45 (97.78%)    
Blood and lymphatic system disorders   
Anaemia   35/45 (77.78%)  51
Anaemia haemolytic autoimmune   1/45 (2.22%)  1
Febrile neutropenia   1/45 (2.22%)  1
Haemolytic anaemia   1/45 (2.22%)  1
Leukopenia   20/45 (44.44%)  44
Lymph node pain   1/45 (2.22%)  1
Lymphadenopathy   1/45 (2.22%)  1
Lymphopenia   6/45 (13.33%)  7
Neutropenia   41/45 (91.11%)  128
Splenomegaly   1/45 (2.22%)  1
Thrombocytopenia   41/45 (91.11%)  79
Cardiac disorders   
Bradycardia   3/45 (6.67%)  3
Cardiac failure congestive   2/45 (4.44%)  2
Cardiac flutter   1/45 (2.22%)  1
Myocardial ischaemia   1/45 (2.22%)  1
Tachycardia   1/45 (2.22%)  1
Ventricular extrasystoles   1/45 (2.22%)  1
Ear and labyrinth disorders   
Cerumen impaction   1/45 (2.22%)  1
Ear congestion   1/45 (2.22%)  1
Ear discomfort   2/45 (4.44%)  2
Ear pain   2/45 (4.44%)  2
Vertigo   1/45 (2.22%)  2
Eye disorders   
Cataract   2/45 (4.44%)  2
Eye irritation   1/45 (2.22%)  1
Eye oedema   2/45 (4.44%)  2
Lacrimation increased   3/45 (6.67%)  3
Ocular hyperaemia   1/45 (2.22%)  1
Periorbital oedema   1/45 (2.22%)  2
Photopsia   1/45 (2.22%)  1
Scleral discolouration   1/45 (2.22%)  1
Vision blurred   6/45 (13.33%)  7
Visual impairment   1/45 (2.22%)  1
Gastrointestinal disorders   
Abdominal discomfort   2/45 (4.44%)  3
Abdominal distension   11/45 (24.44%)  13
Abdominal pain   10/45 (22.22%)  12
Abdominal pain lower   1/45 (2.22%)  1
Abdominal pain upper   5/45 (11.11%)  6
Abdominal tenderness   1/45 (2.22%)  1
Aphthous stomatitis   2/45 (4.44%)  2
Cheilitis   1/45 (2.22%)  1
Colitis   1/45 (2.22%)  1
Colitis ulcerative   1/45 (2.22%)  1
Constipation   19/45 (42.22%)  21
Diarrhoea   24/45 (53.33%)  44
Dry mouth   3/45 (6.67%)  3
Dyspepsia   3/45 (6.67%)  4
Dysphagia   3/45 (6.67%)  3
Eructation   2/45 (4.44%)  2
Flatulence   2/45 (4.44%)  2
Gastritis   1/45 (2.22%)  1
Gingival pain   1/45 (2.22%)  1
Gingivitis   1/45 (2.22%)  1
Glossodynia   1/45 (2.22%)  1
Hypoaesthesia oral   1/45 (2.22%)  1
Lip pain   1/45 (2.22%)  1
Lip swelling   1/45 (2.22%)  1
Nausea   16/45 (35.56%)  17
Odynophagia   1/45 (2.22%)  1
Oral discomfort   1/45 (2.22%)  1
Oral pain   2/45 (4.44%)  2
Painful defaecation   1/45 (2.22%)  1
Stomatitis   1/45 (2.22%)  1
Tongue coated   2/45 (4.44%)  2
Toothache   1/45 (2.22%)  1
Vomiting   11/45 (24.44%)  12
General disorders   
Asthenia   23/45 (51.11%)  28
Axillary pain   1/45 (2.22%)  1
Chest pain   5/45 (11.11%)  7
Chills   1/45 (2.22%)  1
Crepitations   2/45 (4.44%)  2
Early satiety   1/45 (2.22%)  1
Effusion   1/45 (2.22%)  1
Facial pain   1/45 (2.22%)  1
Fatigue   43/45 (95.56%)  70
Feeling abnormal   1/45 (2.22%)  1
Feeling hot   2/45 (4.44%)  2
Influenza like illness   4/45 (8.89%)  4
Irritability   1/45 (2.22%)  1
Local swelling   1/45 (2.22%)  1
Malaise   2/45 (4.44%)  2
Oedema   11/45 (24.44%)  13
Oedema peripheral   16/45 (35.56%)  26
Pain   3/45 (6.67%)  5
Pyrexia   16/45 (35.56%)  18
Tenderness   1/45 (2.22%)  1
Thirst   1/45 (2.22%)  1
Hepatobiliary disorders   
Hepatic function abnormal   1/45 (2.22%)  1
Hyperbilirubinaemia   11/45 (24.44%)  19
Jaundice   1/45 (2.22%)  1
Immune system disorders   
Hypersensitivity   1/45 (2.22%)  1
Infections and infestations   
Bronchitis   2/45 (4.44%)  2
Cellulitis   2/45 (4.44%)  2
Clostridial infection   1/45 (2.22%)  1
Ear infection   1/45 (2.22%)  1
Eye infection staphylococcal   1/45 (2.22%)  1
Fungal infection   4/45 (8.89%)  4
Helicobacter gastritis   1/45 (2.22%)  1
Herpes simplex   1/45 (2.22%)  2
Herpes zoster   2/45 (4.44%)  2
Herpes zoster disseminated   1/45 (2.22%)  1
Infection   2/45 (4.44%)  2
Nasopharyngitis   6/45 (13.33%)  6
Opportunistic infection   1/45 (2.22%)  1
Oral candidiasis   3/45 (6.67%)  3
Otitis media   1/45 (2.22%)  1
Pharyngitis   2/45 (4.44%)  2
Pneumonia   5/45 (11.11%)  6
Respiratory tract infection   3/45 (6.67%)  4
Rhinitis   1/45 (2.22%)  1
Sinusitis   10/45 (22.22%)  18
Tooth abscess   2/45 (4.44%)  2
Tooth infection   1/45 (2.22%)  1
Upper respiratory tract infection   12/45 (26.67%)  35
Urinary tract infection   1/45 (2.22%)  1
Viral infection   2/45 (4.44%)  2
Viral upper respiratory tract infection   1/45 (2.22%)  1
Vulvovaginal mycotic infection   1/45 (2.22%)  1
Injury, poisoning and procedural complications   
Contusion   9/45 (20.00%)  10
Muscle strain   1/45 (2.22%)  1
Splenosis   1/45 (2.22%)  1
Tendon injury   1/45 (2.22%)  1
Thermal burn   1/45 (2.22%)  1
Wound   1/45 (2.22%)  1
Investigations   
Activated partial thromboplastin time prolonged   1/45 (2.22%)  2
Alanine aminotransferase increased   14/45 (31.11%)  27
Aspartate aminotransferase   1/45 (2.22%)  1
Aspartate aminotransferase decreased   7/45 (15.56%)  7
Aspartate aminotransferase increased   15/45 (33.33%)  26
Blood alkaline phosphatase increased   18/45 (40.00%)  18
Blood bilirubin increased   3/45 (6.67%)  5
Blood creatine decreased   2/45 (4.44%)  2
Blood creatinine   4/45 (8.89%)  4
Blood creatinine decreased   3/45 (6.67%)  3
Blood creatinine increased   3/45 (6.67%)  5
Blood glucose increased   1/45 (2.22%)  1
Blood phosphorus   4/45 (8.89%)  4
Blood phosphorus decreased   1/45 (2.22%)  1
Blood phosphorus increased   1/45 (2.22%)  1
Blood potassium decreased   1/45 (2.22%)  1
Blood pressure increased   1/45 (2.22%)  1
Blood urea decreased   4/45 (8.89%)  4
Blood urea increased   15/45 (33.33%)  15
Blood uric acid decreased   5/45 (11.11%)  5
Blood uric acid increased   3/45 (6.67%)  3
Breath sounds abnormal   2/45 (4.44%)  2
Immunoglobulins decreased   1/45 (2.22%)  1
Liver function test abnormal   2/45 (4.44%)  3
Platelet count decreased   2/45 (4.44%)  3
Protein total decreased   1/45 (2.22%)  1
Prothrombin time prolonged   1/45 (2.22%)  3
Troponin   1/45 (2.22%)  1
Weight decreased   13/45 (28.89%)  15
Weight increased   1/45 (2.22%)  1
pH urine abnormal   1/45 (2.22%)  1
Metabolism and nutrition disorders   
Cachexia   1/45 (2.22%)  1
Decreased appetite   17/45 (37.78%)  19
Dehydration   1/45 (2.22%)  1
Hypercalcaemia   1/45 (2.22%)  2
Hyperglycaemia   12/45 (26.67%)  16
Hyperkalaemia   11/45 (24.44%)  14
Hypermagnesaemia   1/45 (2.22%)  1
Hypernatraemia   7/45 (15.56%)  7
Hyperphosphataemia   7/45 (15.56%)  7
Hyperproteinaemia   1/45 (2.22%)  1
Hyperuricaemia   1/45 (2.22%)  1
Hypoalbuminaemia   20/45 (44.44%)  31
Hypocalcaemia   27/45 (60.00%)  43
Hypoglycaemia   3/45 (6.67%)  5
Hypokalaemia   17/45 (37.78%)  20
Hypomagnesaemia   1/45 (2.22%)  1
Hyponatraemia   20/45 (44.44%)  22
Hypophagia   1/45 (2.22%)  1
Hypophosphataemia   5/45 (11.11%)  5
Hypoproteinaemia   21/45 (46.67%)  21
Hypouricaemia   3/45 (6.67%)  4
Tumour lysis syndrome   1/45 (2.22%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia   9/45 (20.00%)  9
Back pain   9/45 (20.00%)  12
Bone pain   2/45 (4.44%)  3
Flank pain   1/45 (2.22%)  1
Groin pain   2/45 (4.44%)  2
Joint swelling   1/45 (2.22%)  1
Limb discomfort   1/45 (2.22%)  1
Muscle spasms   8/45 (17.78%)  19
Muscle tightness   1/45 (2.22%)  1
Muscular weakness   5/45 (11.11%)  5
Musculoskeletal chest pain   1/45 (2.22%)  1
Musculoskeletal discomfort   1/45 (2.22%)  1
Myalgia   3/45 (6.67%)  4
Neck pain   3/45 (6.67%)  3
Pain in extremity   6/45 (13.33%)  9
Pain in jaw   2/45 (4.44%)  2
Tendonitis   1/45 (2.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare   29/45 (64.44%)  35
Nervous system disorders   
Burning sensation   1/45 (2.22%)  1
Dementia   1/45 (2.22%)  1
Disturbance in attention   2/45 (4.44%)  3
Dizziness   16/45 (35.56%)  23
Headache   14/45 (31.11%)  17
Hypoaesthesia   5/45 (11.11%)  6
Lethargy   2/45 (4.44%)  2
Memory impairment   3/45 (6.67%)  3
Migraine with aura   1/45 (2.22%)  1
Neuropathy peripheral   12/45 (26.67%)  13
Paraesthesia   1/45 (2.22%)  1
Peripheral sensory neuropathy   1/45 (2.22%)  1
Post herpetic neuralgia   1/45 (2.22%)  1
Sinus headache   2/45 (4.44%)  2
Somnolence   1/45 (2.22%)  1
Syncope   1/45 (2.22%)  1
Tremor   2/45 (4.44%)  3
Psychiatric disorders   
Agitation   1/45 (2.22%)  1
Anxiety   3/45 (6.67%)  3
Confusional state   2/45 (4.44%)  2
Depression   4/45 (8.89%)  5
Disorientation   1/45 (2.22%)  1
Hallucination   1/45 (2.22%)  1
Insomnia   9/45 (20.00%)  9
Mood altered   1/45 (2.22%)  1
Panic attack   1/45 (2.22%)  1
Psychotic disorder   1/45 (2.22%)  1
Restlessness   1/45 (2.22%)  1
Renal and urinary disorders   
Dysuria   1/45 (2.22%)  1
Haematuria   2/45 (4.44%)  2
Haemorrhage urinary tract   1/45 (2.22%)  1
Nocturia   4/45 (8.89%)  4
Pollakiuria   1/45 (2.22%)  1
Renal failure   2/45 (4.44%)  2
Urethral pain   1/45 (2.22%)  1
Urethral spasm   1/45 (2.22%)  1
Urinary hesitation   1/45 (2.22%)  1
Urinary incontinence   1/45 (2.22%)  1
Urinary retention   2/45 (4.44%)  2
Respiratory, thoracic and mediastinal disorders   
Atelectasis   1/45 (2.22%)  1
Bronchiectasis   1/45 (2.22%)  1
Cough   19/45 (42.22%)  30
Dysphonia   4/45 (8.89%)  4
Dyspnoea   27/45 (60.00%)  34
Dyspnoea exertional   8/45 (17.78%)  8
Epistaxis   5/45 (11.11%)  6
Hyperventilation   1/45 (2.22%)  1
Hypopnoea   1/45 (2.22%)  1
Hypoxia   2/45 (4.44%)  3
Nasal congestion   9/45 (20.00%)  10
Nasal discomfort   2/45 (4.44%)  2
Nasal obstruction   1/45 (2.22%)  1
Oropharyngeal pain   10/45 (22.22%)  13
Pharyngeal oedema   1/45 (2.22%)  1
Pleural effusion   5/45 (11.11%)  5
Pleurisy   1/45 (2.22%)  1
Productive cough   9/45 (20.00%)  10
Pulmonary hypertension   1/45 (2.22%)  1
Rales   2/45 (4.44%)  2
Rhinorrhoea   8/45 (17.78%)  11
Rhonchi   1/45 (2.22%)  1
Sinus congestion   4/45 (8.89%)  4
Tonsillar inflammation   1/45 (2.22%)  2
Upper respiratory tract congestion   1/45 (2.22%)  1
Upper-airway cough syndrome   2/45 (4.44%)  2
Wheezing   5/45 (11.11%)  5
Skin and subcutaneous tissue disorders   
Alopecia   1/45 (2.22%)  1
Blister   1/45 (2.22%)  1
Dry skin   10/45 (22.22%)  10
Erythema   3/45 (6.67%)  4
Hyperhidrosis   5/45 (11.11%)  5
Hypoaesthesia facial   1/45 (2.22%)  2
Nail discolouration   1/45 (2.22%)  1
Night sweats   12/45 (26.67%)  16
Pain of skin   1/45 (2.22%)  1
Petechiae   2/45 (4.44%)  2
Pruritus   13/45 (28.89%)  15
Pyoderma gangrenosum   1/45 (2.22%)  2
Rash   27/45 (60.00%)  40
Rash erythematous   1/45 (2.22%)  2
Rash generalised   2/45 (4.44%)  2
Rash pruritic   7/45 (15.56%)  8
Skin discolouration   1/45 (2.22%)  1
Skin hyperpigmentation   4/45 (8.89%)  4
Skin lesion   7/45 (15.56%)  8
Swelling face   1/45 (2.22%)  1
Urticaria   2/45 (4.44%)  2
Surgical and medical procedures   
Glaucoma drug therapy   1/45 (2.22%)  1
Sinus operation   1/45 (2.22%)  1
Tooth repair   1/45 (2.22%)  1
Vascular disorders   
Deep vein thrombosis   1/45 (2.22%)  1
Haematoma   1/45 (2.22%)  1
Hot flush   2/45 (4.44%)  2
Hypotension   4/45 (8.89%)  4
Lymphoedema   1/45 (2.22%)  1
Pallor   5/45 (11.11%)  6
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00096044     History of Changes
Other Study ID Numbers: CDR0000391767
RPCI-I-18103 ( Other Identifier: Roswell Park Cancer Institute )
CELGENE-RV-CLL-PI-005 ( Other Grant/Funding Number: Celgene )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: April 24, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017