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A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma

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ClinicalTrials.gov Identifier: NCT01973387
Recruitment Status : Completed
First Posted : October 31, 2013
Results First Posted : February 23, 2017
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions Drug: Rituximab
Drug: Ibrutinib
Enrollment 160
Recruitment Details A Randomized, Multicenter, Open-Label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 (Ibrutinib) versus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Pre-assignment Details  
Arm/Group Title Ibrutinib Rituximab
Hide Arm/Group Description Receive 420 mg ibrutinib (3 x 140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first. Receive rituximab IV infusion 375 mg/m2 on Day 1 of Cycle 1 and 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).
Period Title: Overall Study
Started 106 54
Treated 104 52
Completed 0 36
Not Completed 106 18
Reason Not Completed
Adverse Event             14             4
Withdrawal by Subject             7             4
Study terminated by sponsor             63             0
Progressive disease or relapse             16             5
Death             4             3
Randomized, not treated             2             2
Arm/Group Title Ibrutinib Rituximab Total
Hide Arm/Group Description Receive 420 mg ibrutinib (3 x 140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first. Receive rituximab IV infusion 375 mg/m2 on Day 1 of Cycle 1 and 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24). Total of all reporting groups
Overall Number of Baseline Participants 106 54 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 54 participants 160 participants
63.6  (10.36) 63.6  (13.04) 63.6  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 54 participants 160 participants
Female
29
  27.4%
18
  33.3%
47
  29.4%
Male
77
  72.6%
36
  66.7%
113
  70.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 54 participants 160 participants
Australia
15
  14.2%
9
  16.7%
24
  15.0%
China
87
  82.1%
44
  81.5%
131
  81.9%
Malaysia
1
   0.9%
1
   1.9%
2
   1.3%
Taiwan, Province Of China
3
   2.8%
0
   0.0%
3
   1.9%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for progressive disease (PD): New enlarged nodes greater than (>)1.5 centimeter (cm), new hepatomegaly or splenomegaly, or other organ infiltrates; greater than or equal to (>=)50 percent (%) increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; New cytopenia (Hemoglobin b [Hgb] or platelets) attributable to chronic lymphocytic leukemia (CLL) and transformation to a more aggressive histology.
Time Frame From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Ibrutinib Rituximab
Hide Arm/Group Description:
Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
Treatment Arm B received rituximab intravenous (IV) infusion 375 milligrams per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
Overall Number of Participants Analyzed 106 54
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
8.38
(8.31 to 9.03)
[1]
Median, lower limit and upper limit of 95% CI was not estimable due to lesser number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibrutinib, Rituximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.178
Confidence Interval (2-Sided) 95%
0.109 to 0.291
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- >=50% drop in lymphocyte count from baseline or <=4.0*10^9/L with following: >=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, >=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils >1.5*10^9/L, Platelets>100000/mcL and Hgb>11 g/dL or >=50% improvement over baseline in all.
Time Frame From the date of randomization to disease progression (Up to 3.7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Ibrutinib Rituximab
Hide Arm/Group Description:
Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
Treatment Arm B received rituximab intravenous (IV) infusion 375 milligrams per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
Overall Number of Participants Analyzed 106 54
Measure Type: Number
Unit of Measure: participants
66 4
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the interval between the date of randomization and the date of death from any cause.
Time Frame From the date of randomization to the date of death (Up to 3.7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Ibrutinib Rituximab
Hide Arm/Group Description:
Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
Treatment Arm B received rituximab intravenous (IV) infusion 375 milligrams per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
Overall Number of Participants Analyzed 106 54
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(19.52 to NA)
[1]
Median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events.
[2]
Median and upper limit of 95% CI was not estimable due to lesser number of events.
4.Secondary Outcome
Title Number of Participants With Sustained Hematologic Improvement
Hide Description Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.
Time Frame From the date of randomization to disease progression (Up to 3.7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Ibrutinib Rituximab
Hide Arm/Group Description:
Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
Treatment Arm B received rituximab intravenous (IV) infusion 375 milligrams per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
Overall Number of Participants Analyzed 106 54
Measure Type: Number
Unit of Measure: participants
Hemoglobin 43 14
Platelets 48 12
5.Secondary Outcome
Title Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms
Hide Description The most common disease-related symptoms associated with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (fatigue, weight loss, fevers, night sweats, and abdominal discomfort/splenomegaly) were reported by grade.
Time Frame From the date of randomization to disease progression (Up to 3.7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Ibrutinib Rituximab
Hide Arm/Group Description:
Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
Treatment Arm B received rituximab intravenous (IV) infusion 375 milligrams per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
Overall Number of Participants Analyzed 106 54
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame Screening up to follow up phase (approximately 3.7 years)
Adverse Event Reporting Description Safety analysis set included all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Ibrutinib Rituximab
Hide Arm/Group Description Receive 420 mg ibrutinib (3 x 140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first. Receive rituximab IV infusion 375 mg/m2 on Day 1 of Cycle 1 and 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).
All-Cause Mortality
Ibrutinib Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   21/104 (20.19%)   20/52 (38.46%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ibrutinib Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   56/104 (53.85%)   17/52 (32.69%) 
Blood and lymphatic system disorders     
Agranulocytosis * 1  2/104 (1.92%)  0/52 (0.00%) 
Anaemia * 1  1/104 (0.96%)  0/52 (0.00%) 
Bone Marrow Failure * 1  1/104 (0.96%)  0/52 (0.00%) 
Febrile Neutropenia * 1  1/104 (0.96%)  1/52 (1.92%) 
Haemolytic Anaemia * 1  1/104 (0.96%)  0/52 (0.00%) 
Haemorrhagic Diathesis * 1  1/104 (0.96%)  0/52 (0.00%) 
Lymphadenitis * 1  3/104 (2.88%)  0/52 (0.00%) 
Lymphadenopathy * 1  1/104 (0.96%)  0/52 (0.00%) 
Splenic Infarction * 1  1/104 (0.96%)  0/52 (0.00%) 
Thrombocytopenia * 1  2/104 (1.92%)  0/52 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  0/104 (0.00%)  1/52 (1.92%) 
Atrial Fibrillation * 1  3/104 (2.88%)  0/52 (0.00%) 
Cardiac Arrest * 1  1/104 (0.96%)  0/52 (0.00%) 
Cardiac Failure * 1  3/104 (2.88%)  1/52 (1.92%) 
Cardiac Tamponade * 1  1/104 (0.96%)  0/52 (0.00%) 
Coronary Artery Disease * 1  1/104 (0.96%)  0/52 (0.00%) 
Myocardial Infarction * 1  1/104 (0.96%)  0/52 (0.00%) 
Eye disorders     
Cataract * 1  1/104 (0.96%)  0/52 (0.00%) 
Dry Eye * 1  1/104 (0.96%)  0/52 (0.00%) 
Eye Irritation * 1  1/104 (0.96%)  0/52 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  0/104 (0.00%)  1/52 (1.92%) 
Diarrhoea * 1  1/104 (0.96%)  0/52 (0.00%) 
Gastrointestinal Haemorrhage * 1  1/104 (0.96%)  0/52 (0.00%) 
General disorders     
Chest Discomfort * 1  1/104 (0.96%)  0/52 (0.00%) 
Death * 1  3/104 (2.88%)  0/52 (0.00%) 
Local Swelling * 1  0/104 (0.00%)  1/52 (1.92%) 
Pyrexia * 1  3/104 (2.88%)  3/52 (5.77%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/104 (0.96%)  0/52 (0.00%) 
Hepatic Function Abnormal * 1  0/104 (0.00%)  1/52 (1.92%) 
Infections and infestations     
Anal Abscess * 1  2/104 (1.92%)  0/52 (0.00%) 
Appendicitis * 1  1/104 (0.96%)  0/52 (0.00%) 
Appendicitis Perforated * 1  1/104 (0.96%)  0/52 (0.00%) 
Bronchitis * 1  2/104 (1.92%)  0/52 (0.00%) 
Cellulitis * 1  1/104 (0.96%)  0/52 (0.00%) 
Conjunctivitis * 1  1/104 (0.96%)  0/52 (0.00%) 
Gangrene * 1  0/104 (0.00%)  1/52 (1.92%) 
Herpes Virus Infection * 1  1/104 (0.96%)  0/52 (0.00%) 
Herpes Zoster * 1  0/104 (0.00%)  1/52 (1.92%) 
Infected Cyst * 1  1/104 (0.96%)  0/52 (0.00%) 
Infection * 1  0/104 (0.00%)  2/52 (3.85%) 
Infective Exacerbation of Bronchiectasis * 1  0/104 (0.00%)  1/52 (1.92%) 
Influenza * 1  0/104 (0.00%)  1/52 (1.92%) 
Lung Abscess * 1  1/104 (0.96%)  0/52 (0.00%) 
Lung Infection * 1  12/104 (11.54%)  6/52 (11.54%) 
Pneumonia * 1  5/104 (4.81%)  1/52 (1.92%) 
Pneumonia Viral * 1  0/104 (0.00%)  1/52 (1.92%) 
Postoperative Wound Infection * 1  1/104 (0.96%)  0/52 (0.00%) 
Pyelonephritis Chronic * 1  1/104 (0.96%)  0/52 (0.00%) 
Salmonella Sepsis * 1  0/104 (0.00%)  1/52 (1.92%) 
Sepsis * 1  2/104 (1.92%)  0/52 (0.00%) 
Septic Shock * 1  1/104 (0.96%)  0/52 (0.00%) 
Serratia Bacteraemia * 1  1/104 (0.96%)  0/52 (0.00%) 
Skin Infection * 1  2/104 (1.92%)  0/52 (0.00%) 
Staphylococcal Sepsis * 1  1/104 (0.96%)  0/52 (0.00%) 
Tonsillitis * 1  1/104 (0.96%)  0/52 (0.00%) 
Upper Respiratory Tract Infection * 1  1/104 (0.96%)  0/52 (0.00%) 
Urinary Tract Infection * 1  3/104 (2.88%)  0/52 (0.00%) 
Injury, poisoning and procedural complications     
Femoral Neck Fracture * 1  1/104 (0.96%)  0/52 (0.00%) 
Laceration * 1  1/104 (0.96%)  0/52 (0.00%) 
Lumbar Vertebral Fracture * 1  2/104 (1.92%)  0/52 (0.00%) 
Post Procedural Haemorrhage * 1  1/104 (0.96%)  0/52 (0.00%) 
Procedural Pneumothorax * 1  1/104 (0.96%)  0/52 (0.00%) 
Splenic Rupture * 1  1/104 (0.96%)  0/52 (0.00%) 
Thoracic Vertebral Fracture * 1  1/104 (0.96%)  0/52 (0.00%) 
Investigations     
Neutrophil Count Decreased * 1  0/104 (0.00%)  1/52 (1.92%) 
Platelet Count Decreased * 1  2/104 (1.92%)  1/52 (1.92%) 
Metabolism and nutrition disorders     
Ketoacidosis * 1  1/104 (0.96%)  0/52 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Protrusion * 1  1/104 (0.96%)  0/52 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Diffuse Large B-Cell Lymphoma * 1  1/104 (0.96%)  0/52 (0.00%) 
Gastrointestinal Stromal Tumour * 1  1/104 (0.96%)  0/52 (0.00%) 
Lung Adenocarcinoma * 1  1/104 (0.96%)  0/52 (0.00%) 
Malignant Melanoma * 1  1/104 (0.96%)  0/52 (0.00%) 
Richter's Syndrome * 1  1/104 (0.96%)  0/52 (0.00%) 
Skin Cancer * 1  1/104 (0.96%)  0/52 (0.00%) 
Nervous system disorders     
Cerebral Haemorrhage * 1  0/104 (0.00%)  1/52 (1.92%) 
Cerebral Infarction * 1  1/104 (0.96%)  0/52 (0.00%) 
Lacunar Infarction * 1  1/104 (0.96%)  0/52 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  1/104 (0.96%)  0/52 (0.00%) 
Renal Cyst * 1  1/104 (0.96%)  0/52 (0.00%) 
Renal Impairment * 1  1/104 (0.96%)  0/52 (0.00%) 
Reproductive system and breast disorders     
Prostatitis * 1  1/104 (0.96%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome * 1  1/104 (0.96%)  0/52 (0.00%) 
Chronic Obstructive Pulmonary Disease * 1  2/104 (1.92%)  0/52 (0.00%) 
Cough * 1  1/104 (0.96%)  0/52 (0.00%) 
Dyspnoea * 1  1/104 (0.96%)  0/52 (0.00%) 
Pleural Effusion * 1  2/104 (1.92%)  0/52 (0.00%) 
Pulmonary Mass * 1  1/104 (0.96%)  0/52 (0.00%) 
Respiratory Failure * 1  3/104 (2.88%)  1/52 (1.92%) 
Vascular disorders     
Circulatory Collapse * 1  1/104 (0.96%)  0/52 (0.00%) 
Haematoma * 1  1/104 (0.96%)  0/52 (0.00%) 
Varicose Vein * 1  1/104 (0.96%)  0/52 (0.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibrutinib Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   103/104 (99.04%)   46/52 (88.46%) 
Blood and lymphatic system disorders     
Anaemia * 1  20/104 (19.23%)  5/52 (9.62%) 
Leukocytosis * 1  13/104 (12.50%)  0/52 (0.00%) 
Monocytopenia * 1  0/104 (0.00%)  3/52 (5.77%) 
Neutropenia * 1  26/104 (25.00%)  11/52 (21.15%) 
Thrombocytopenia * 1  18/104 (17.31%)  3/52 (5.77%) 
Ear and labyrinth disorders     
Vertigo * 1  13/104 (12.50%)  0/52 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  6/104 (5.77%)  0/52 (0.00%) 
Abdominal Pain Upper * 1  7/104 (6.73%)  1/52 (1.92%) 
Constipation * 1  18/104 (17.31%)  0/52 (0.00%) 
Diarrhoea * 1  41/104 (39.42%)  4/52 (7.69%) 
Mouth Ulceration * 1  15/104 (14.42%)  3/52 (5.77%) 
Nausea * 1  18/104 (17.31%)  1/52 (1.92%) 
Vomiting * 1  8/104 (7.69%)  3/52 (5.77%) 
General disorders     
Chills * 1  1/104 (0.96%)  9/52 (17.31%) 
Fatigue * 1  30/104 (28.85%)  6/52 (11.54%) 
Oedema Peripheral * 1  10/104 (9.62%)  2/52 (3.85%) 
Pyrexia * 1  27/104 (25.96%)  14/52 (26.92%) 
Infections and infestations     
Lung Infection * 1  17/104 (16.35%)  3/52 (5.77%) 
Nasopharyngitis * 1  19/104 (18.27%)  0/52 (0.00%) 
Upper Respiratory Tract Infection * 1  29/104 (27.88%)  7/52 (13.46%) 
Injury, poisoning and procedural complications     
Contusion * 1  6/104 (5.77%)  0/52 (0.00%) 
Infusion Related Reaction * 1  0/104 (0.00%)  3/52 (5.77%) 
Investigations     
Alanine Aminotransferase Increased * 1  7/104 (6.73%)  3/52 (5.77%) 
Aspartate Aminotransferase Increased * 1  6/104 (5.77%)  3/52 (5.77%) 
Blood Creatinine Increased * 1  6/104 (5.77%)  0/52 (0.00%) 
Blood Lactate Dehydrogenase Increased * 1  10/104 (9.62%)  1/52 (1.92%) 
Haemoglobin Decreased * 1  15/104 (14.42%)  6/52 (11.54%) 
Lymphocyte Count Increased * 1  15/104 (14.42%)  0/52 (0.00%) 
Neutrophil Count Decreased * 1  36/104 (34.62%)  20/52 (38.46%) 
Platelet Count Decreased * 1  33/104 (31.73%)  14/52 (26.92%) 
Weight Decreased * 1  8/104 (7.69%)  3/52 (5.77%) 
White Blood Cell Count Decreased * 1  9/104 (8.65%)  9/52 (17.31%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  11/104 (10.58%)  2/52 (3.85%) 
Hyperglycaemia * 1  11/104 (10.58%)  2/52 (3.85%) 
Hyperuricaemia * 1  8/104 (7.69%)  2/52 (3.85%) 
Hypokalaemia * 1  7/104 (6.73%)  6/52 (11.54%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  10/104 (9.62%)  1/52 (1.92%) 
Back Pain * 1  9/104 (8.65%)  0/52 (0.00%) 
Muscle Spasms * 1  9/104 (8.65%)  0/52 (0.00%) 
Pain in Extremity * 1  7/104 (6.73%)  0/52 (0.00%) 
Nervous system disorders     
Dizziness * 1  6/104 (5.77%)  0/52 (0.00%) 
Headache * 1  11/104 (10.58%)  2/52 (3.85%) 
Psychiatric disorders     
Insomnia * 1  7/104 (6.73%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  33/104 (31.73%)  4/52 (7.69%) 
Epistaxis * 1  12/104 (11.54%)  0/52 (0.00%) 
Oropharyngeal Pain * 1  13/104 (12.50%)  1/52 (1.92%) 
Productive Cough * 1  6/104 (5.77%)  0/52 (0.00%) 
Skin and subcutaneous tissue disorders     
Petechiae * 1  6/104 (5.77%)  0/52 (0.00%) 
Rash * 1  31/104 (29.81%)  3/52 (5.77%) 
Skin Haemorrhage * 1  11/104 (10.58%)  0/52 (0.00%) 
Vascular disorders     
Hypertension * 1  7/104 (6.73%)  3/52 (5.77%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Name/Title: Vice President (VP)
Organization: Janssen Research & Development, LLC
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01973387     History of Changes
Other Study ID Numbers: CR102604
PCI-32765CLL3002 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: October 25, 2013
First Posted: October 31, 2013
Results First Submitted: November 29, 2016
Results First Posted: February 23, 2017
Last Update Posted: July 24, 2018