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Trial record 1 of 1 for:    PCYC-1130
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A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve CLL or SLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02264574
Recruitment Status : Active, not recruiting
First Posted : October 15, 2014
Results First Posted : April 16, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
Small-Cell Lymphoma
Interventions Drug: Ibrutinib
Drug: Obinutuzumab
Drug: Chlorambucil
Enrollment 229
Recruitment Details This study was conducted in 71 sites: 8 in the US, 36 in the EU, and 27 sites in 6 additional countries (Canada, Australia, New Zealand, Russia, Israel, Turkey). The first subject consented 06Oct2014 and the database lock for the last visit of the last subjects was 26Mar2018.
Pre-assignment Details Eligible subjects required to have had a diagnosis of active CLL/SLL conformant to IWCLL 2008 criteria. All subjects were required to have measurable nodal disease. Key exclusion criteria included any previous CLL/SLL treatment; known lymphoma or leukemia of the central nervous system, history/current evidence of Richter's transformation.
Arm/Group Title IBR +OB CLB +OB
Hide Arm/Group Description Ibrutinib 420 mg daily + 6-cycle obinutuzumab Chlorambucil 0.5 mg/kg on days 1 and 15 of each 28-day cycle up to 6 cycles + 6-cycle obinutuzumab
Period Title: Overall Study
Started 113 116
Completed 107 108
Not Completed 6 8
Reason Not Completed
Withdrawal by Subject             6             5
various other reasons             0             3
Arm/Group Title IBR + OB CLB + OB Total
Hide Arm/Group Description Ibrutinib 420 mg daily + 6-cycle obinutuzumab Chlorambucil 0.5 mg/kg on days 1 and 15 of each 28-day cycle upto 6 cycles + 6-cycle obinutuzumab Total of all reporting groups
Overall Number of Baseline Participants 113 116 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 229 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  19.5%
24
  20.7%
46
  20.1%
>=65 years
91
  80.5%
92
  79.3%
183
  79.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 113 participants 116 participants 229 participants
70.0
(47 to 87)
72.0
(40 to 86)
71.0
(40 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 229 participants
Female
46
  40.7%
37
  31.9%
83
  36.2%
Male
67
  59.3%
79
  68.1%
146
  63.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 229 participants
Hispanic or Latino
4
   3.5%
6
   5.2%
10
   4.4%
Not Hispanic or Latino
109
  96.5%
110
  94.8%
219
  95.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 229 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.9%
2
   1.7%
3
   1.3%
Native Hawaiian or Other Pacific Islander
1
   0.9%
1
   0.9%
2
   0.9%
Black or African American
2
   1.8%
2
   1.7%
4
   1.7%
White
109
  96.5%
111
  95.7%
220
  96.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 229 participants
United States 13 11 24
Czechia 8 6 14
United Kingdom 2 2 4
Spain 17 9 26
Russia 11 9 20
New Zealand 0 9 9
Canada 3 5 8
Austria 5 6 11
Sweden 8 3 11
Turkey 15 13 28
Belgium 2 2 4
Poland 2 2 4
Italy 13 15 28
Israel 5 11 16
France 3 5 8
Australia 6 8 14
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS is defined as time from the date randomization to the date of first IRC-confirmed disease progression (PD) or date of death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of disease progression was conducted in accordance with the IWCLL 2008 criteria with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of disease progression will not be considered progressive disease. As the median PFS was not reached in the experimental (Ibr+Ob) arm at the time of the analysis, Kaplan Meier point estimates of the PFS rate at 30 months are presented.
Time Frame The primary analysis was performed after observing 94 PFS events as pre-specified in the study protocol. The median follow-up time was 31.3 months at the time of the analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat
Arm/Group Title IBR + OB CLB + OB
Hide Arm/Group Description:
Ibrutinib 420 mg daily + 6-cycle obinutuzumab
Chlorambucil 0.5 mg/kg on days 1 and 15 of each 28-day cycle upto 6 cycles + 6-cycle obinutuzumab
Overall Number of Participants Analyzed 113 116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
78.5
(69.9 to 85.2)
31.1
(22.5 to 40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IBR + OB, CLB + OB
Comments The treatment effect was tested with an unstratified log rank test. The hazard ratio and its 95% confidence internval were based on a Cox regression model with treatment as the only covariate.
Type of Statistical Test Superiority
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 0.231
Confidence Interval (2-Sided) 95%
0.145 to 0.367
Estimation Comments [Not Specified]
2.Secondary Outcome
Title PFS in High-risk Subpopulation
Hide Description PFS by IRC as defined in primary endpoint was analyzed within a high-risk subpopulation which defined as randomization subjects with del17p/TP53 mutation or del 11q at baseline per central lab results.As the median PFS was not reached in the experimental (Ibr+Ob) arm at time of analysis, Kaplan Meier point estimates of the PFS rate at 30 months was presented.
Time Frame Results at an overall median follow-up of 31.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
High-risk Subpopulation
Arm/Group Title IBR + OB CLB + OB
Hide Arm/Group Description:
Ibrutinib 420 mg daily + 6-cycle obinutuzumab
Chlorambucil 0.5 mg/kg on days 1 and 15 of each 28-day cycle upto 6 cycles + 6-cycle obinutuzumab
Overall Number of Participants Analyzed 30 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent
82.4
(62.7 to 92.3)
14.1
(5.3 to 26.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IBR + OB, CLB + OB
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.119
Confidence Interval (2-Sided) 95%
0.046 to 0.307
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of Sustained Hemoglobin Improvement
Hide Description Percent of subjects with hemoglobin increase ≥ 2 g/dL over baseline continuously for ≥ 56 days without blood transfusions or growth factors.
Time Frame Results at an overall median follow-up time of 31.3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title IBR + OB CLB + OB
Hide Arm/Group Description:
Ibrutinib 420 mg daily + 6-cycle obinutuzumab
Chlorambucil 0.5 mg/kg on days 1 and 15 of each 28-day cycle upto 6 cycles + 6-cycle obinutuzumab
Overall Number of Participants Analyzed 113 116
Measure Type: Number
Unit of Measure: percentage of participants
39.8 44.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IBR + OB, CLB + OB
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.5253
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame From first dose of study drug up to 30 days after the last dose of study drug
Adverse Event Reporting Description There is 1 patient in Clb+Ob arm that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
 
Arm/Group Title IBR +OB CLB +OB
Hide Arm/Group Description Ibrutinib 420 mg daily + 6-cycle obinutuzumab Chlorambucil 0.5 mg/kg on days 1 and 15 of each 28-day cycle upto 6 cycles + 6-cycle obinutuzumab
All-Cause Mortality
IBR +OB CLB +OB
Affected / at Risk (%) Affected / at Risk (%)
Total   10/113 (8.85%)   3/115 (2.61%) 
Show Serious Adverse Events Hide Serious Adverse Events
IBR +OB CLB +OB
Affected / at Risk (%) Affected / at Risk (%)
Total   65/113 (57.52%)   40/115 (34.78%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  4/113 (3.54%)  7/115 (6.09%) 
Thrombocytopenia  1  3/113 (2.65%)  1/115 (0.87%) 
Neutropenia  1  2/113 (1.77%)  0/115 (0.00%) 
Anaemia  1  1/113 (0.88%)  2/115 (1.74%) 
Aplastic anaemia  1  1/113 (0.88%)  0/115 (0.00%) 
Leukopenia  1  1/113 (0.88%)  0/115 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  5/113 (4.42%)  0/115 (0.00%) 
Acute coronary syndrome  1  3/113 (2.65%)  0/115 (0.00%) 
Acute myocardial infarction  1  2/113 (1.77%)  1/115 (0.87%) 
Angina pectoris  1  2/113 (1.77%)  0/115 (0.00%) 
Atrial tachycardia  1  1/113 (0.88%)  0/115 (0.00%) 
Cardiac arrest  1  1/113 (0.88%)  0/115 (0.00%) 
Cardiac failure  1  1/113 (0.88%)  0/115 (0.00%) 
Cardiac failure congestive  1  1/113 (0.88%)  0/115 (0.00%) 
Myocardial infarction  1  1/113 (0.88%)  0/115 (0.00%) 
Pericarditis  1  1/113 (0.88%)  0/115 (0.00%) 
Myocardial ischaemia  1  0/113 (0.00%)  1/115 (0.87%) 
Endocrine disorders     
Goitre  1  1/113 (0.88%)  0/115 (0.00%) 
Eye disorders     
Cataract  1  1/113 (0.88%)  0/115 (0.00%) 
Retinal detachment  1  1/113 (0.88%)  0/115 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/113 (1.77%)  0/115 (0.00%) 
Small intestinal obstruction  1  1/113 (0.88%)  1/115 (0.87%) 
Diarrhea  1  1/113 (0.88%)  0/115 (0.00%) 
Dyspepsia  1  1/113 (0.88%)  0/115 (0.00%) 
Gastritis  1  1/113 (0.88%)  0/115 (0.00%) 
Haemorrhoids  1  1/113 (0.88%)  0/115 (0.00%) 
Impaired gastric emptying  1  1/113 (0.88%)  0/115 (0.00%) 
Inguinal hernia  1  1/113 (0.88%)  0/115 (0.00%) 
Large intestine polyp  1  1/113 (0.88%)  0/115 (0.00%) 
Oesophageal rupture  1  1/113 (0.88%)  0/115 (0.00%) 
Proctitis  1  1/113 (0.88%)  0/115 (0.00%) 
Nausea  1  0/113 (0.00%)  2/115 (1.74%) 
Constipation  1  0/113 (0.00%)  1/115 (0.87%) 
General disorders     
Pyrexia  1  4/113 (3.54%)  4/115 (3.48%) 
Catheter site haematoma  1  1/113 (0.88%)  0/115 (0.00%) 
Death  1  1/113 (0.88%)  0/115 (0.00%) 
Multi-organ disorder  1  1/113 (0.88%)  0/115 (0.00%) 
Sudden Death  1  1/113 (0.88%)  0/115 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/113 (0.88%)  0/115 (0.00%) 
Cholecystitis  1  0/113 (0.00%)  1/115 (0.87%) 
Infections and infestations     
Pneumonia  1  6/113 (5.31%)  5/115 (4.35%) 
Gastroenteritis  1  2/113 (1.77%)  1/115 (0.87%) 
Urinary tract infection  1  2/113 (1.77%)  1/115 (0.87%) 
Pharyngitis  1  1/113 (0.88%)  1/115 (0.87%) 
Abscess of salivary gland  1  1/113 (0.88%)  0/115 (0.00%) 
Bacterial sepsis  1  1/113 (0.88%)  0/115 (0.00%) 
Bronchitis  1  1/113 (0.88%)  0/115 (0.00%) 
Bronchopulmonary aspergillosis  1  1/113 (0.88%)  0/115 (0.00%) 
Bursitis infective staphylococcal  1  1/113 (0.88%)  0/115 (0.00%) 
Cellulitis  1  1/113 (0.88%)  0/115 (0.00%) 
Escherichia sepsis  1  1/113 (0.88%)  0/115 (0.00%) 
Escherichia urinary tract infection  1  1/113 (0.88%)  0/115 (0.00%) 
Herpes Zoster  1  1/113 (0.88%)  0/115 (0.00%) 
Infective aneurysm  1  1/113 (0.88%)  0/115 (0.00%) 
Listeria sepsis  1  1/113 (0.88%)  0/115 (0.00%) 
Lower respiratory tract infection  1  1/113 (0.88%)  0/115 (0.00%) 
Pneumocystis jirovecii pneumonia  1  1/113 (0.88%)  0/115 (0.00%) 
Pneumonia bacterial  1  1/113 (0.88%)  0/115 (0.00%) 
Pneumonia klebsiella  1  1/113 (0.88%)  0/115 (0.00%) 
Respiratory tract infection  1  1/113 (0.88%)  0/115 (0.00%) 
Septic shock  1  1/113 (0.88%)  0/115 (0.00%) 
Soft tissue infection  1  1/113 (0.88%)  0/115 (0.00%) 
Streptococcal bacteraemia  1  1/113 (0.88%)  0/115 (0.00%) 
Upper respiratory tract infection  1  1/113 (0.88%)  0/115 (0.00%) 
Urosepsis  1  1/113 (0.88%)  0/115 (0.00%) 
Sepsis  1  0/113 (0.00%)  2/115 (1.74%) 
Device related infection  1  0/113 (0.00%)  1/115 (0.87%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  2/113 (1.77%)  8/115 (6.96%) 
Concussion  1  1/113 (0.88%)  1/115 (0.87%) 
Hip fracture  1  1/113 (0.88%)  1/115 (0.87%) 
Femur fracture  1  1/113 (0.88%)  0/115 (0.00%) 
Incisional hernia  1  1/113 (0.88%)  0/115 (0.00%) 
Rib fracture  1  1/113 (0.88%)  0/115 (0.00%) 
Spinal compression fracture  1  1/113 (0.88%)  0/115 (0.00%) 
Thoracic vertebral fracture  1  1/113 (0.88%)  0/115 (0.00%) 
Traumatic haematoma  1  1/113 (0.88%)  0/115 (0.00%) 
Upper limb fracture  1  1/113 (0.88%)  0/115 (0.00%) 
Accidental overdose  1  0/113 (0.00%)  1/115 (0.87%) 
Craniocerebral injury  1  0/113 (0.00%)  1/115 (0.87%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  1/113 (0.88%)  0/115 (0.00%) 
Hypokalaemia  1  1/113 (0.88%)  0/115 (0.00%) 
Hypomagnesaemia  1  1/113 (0.88%)  0/115 (0.00%) 
Tumour lysis syndrome  1  0/113 (0.00%)  5/115 (4.35%) 
Dehydration  1  0/113 (0.00%)  1/115 (0.87%) 
Hyponatraemia  1  0/113 (0.00%)  1/115 (0.87%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  2/113 (1.77%)  0/115 (0.00%) 
Arthritis  1  1/113 (0.88%)  0/115 (0.00%) 
Compartment syndrome  1  1/113 (0.88%)  0/115 (0.00%) 
Inclusion body myositis  1  1/113 (0.88%)  0/115 (0.00%) 
Osteolysis  1  0/113 (0.00%)  1/115 (0.87%) 
Osteonecrosis of jaw  1  0/113 (0.00%)  1/115 (0.87%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  1/113 (0.88%)  0/115 (0.00%) 
Adenocarcinoma of colon  1  1/113 (0.88%)  0/115 (0.00%) 
Basal cell carcinoma  1  1/113 (0.88%)  0/115 (0.00%) 
Benign renal neoplasm  1  1/113 (0.88%)  0/115 (0.00%) 
Colorectal cancer  1  1/113 (0.88%)  0/115 (0.00%) 
Colorectal cancer metastatic  1  1/113 (0.88%)  0/115 (0.00%) 
Invasive ductal breast carcinoma  1  1/113 (0.88%)  0/115 (0.00%) 
Malignant melanoma  1  1/113 (0.88%)  0/115 (0.00%) 
Myelodysplastic syndrome  1  1/113 (0.88%)  0/115 (0.00%) 
Non-small cell lung cancer  1  1/113 (0.88%)  0/115 (0.00%) 
Osteoma  1  1/113 (0.88%)  0/115 (0.00%) 
Squamous cell carcinoma  1  1/113 (0.88%)  0/115 (0.00%) 
Chronic lymphocytic leukaemia  1  0/113 (0.00%)  1/115 (0.87%) 
Essential thrombocythaemia  1  0/113 (0.00%)  1/115 (0.87%) 
Kaposi's sarcoma  1  0/113 (0.00%)  1/115 (0.87%) 
Keratoacanthoma  1  0/113 (0.00%)  1/115 (0.87%) 
Neuroendocrine carcinoma of the skin  1  0/113 (0.00%)  1/115 (0.87%) 
Prostate Cancer  1  0/113 (0.00%)  1/115 (0.87%) 
Nervous system disorders     
Cerebrovascular accident  1  2/113 (1.77%)  0/115 (0.00%) 
Transient ischaemic attack  1  2/113 (1.77%)  0/115 (0.00%) 
Cerebral ischaemia  1  1/113 (0.88%)  0/115 (0.00%) 
Depressed level of consciousness  1  1/113 (0.88%)  0/115 (0.00%) 
Ischaemic stroke  1  1/113 (0.88%)  0/115 (0.00%) 
Syncope  1  1/113 (0.88%)  0/115 (0.00%) 
Headache  1  0/113 (0.00%)  1/115 (0.87%) 
Loss of consciousness  1  0/113 (0.00%)  1/115 (0.87%) 
Seizure  1  0/113 (0.00%)  1/115 (0.87%) 
Psychiatric disorders     
Acute psychosis  1  1/113 (0.88%)  0/115 (0.00%) 
Complete Suicide  1  1/113 (0.88%)  0/115 (0.00%) 
Renal and urinary disorders     
Renal failure  1  2/113 (1.77%)  0/115 (0.00%) 
Acute kidney injury  1  1/113 (0.88%)  1/115 (0.87%) 
Urinary retention  1  1/113 (0.88%)  1/115 (0.87%) 
Nephrolithiasis  1  1/113 (0.88%)  0/115 (0.00%) 
Reproductive system and breast disorders     
Uterine prolapse  1  1/113 (0.88%)  0/115 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  1/113 (0.88%)  1/115 (0.87%) 
Bronchitis chronic  1  1/113 (0.88%)  0/115 (0.00%) 
Haemoptysis  1  1/113 (0.88%)  0/115 (0.00%) 
Pleural effusion  1  1/113 (0.88%)  0/115 (0.00%) 
Productive cough  1  1/113 (0.88%)  0/115 (0.00%) 
Acute respiratory failure  1  0/113 (0.00%)  1/115 (0.87%) 
Pulmonary embolism  1  0/113 (0.00%)  1/115 (0.87%) 
Vascular disorders     
Peripheral ischaemia  1  1/113 (0.88%)  0/115 (0.00%) 
Hypertension  1  0/113 (0.00%)  1/115 (0.87%) 
Venous thrombosis limb  1  0/113 (0.00%)  1/115 (0.87%) 
1
Term from vocabulary, MedDRA Version 20.1
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 5%
IBR +OB CLB +OB
Affected / at Risk (%) Affected / at Risk (%)
Total   112/113 (99.12%)   111/115 (96.52%) 
Blood and lymphatic system disorders     
Neutropenia  1  49/113 (43.36%)  73/115 (63.48%) 
Thrombocytopenia  1  39/113 (34.51%)  29/115 (25.22%) 
Anaemia  1  19/113 (16.81%)  28/115 (24.35%) 
Spontaneous haematoma  1  10/113 (8.85%)  1/115 (0.87%) 
Cardiac disorders     
Atrial fibrillation  1  14/113 (12.39%)  0/115 (0.00%) 
Palpitations  1  7/113 (6.19%)  3/115 (2.61%) 
Eye disorders     
Cataract  1  9/113 (7.96%)  1/115 (0.87%) 
Vision blurred  1  8/113 (7.08%)  7/115 (6.09%) 
Lacrimation increased  1  6/113 (5.31%)  5/115 (4.35%) 
Gastrointestinal disorders     
Diarrhea  1  38/113 (33.63%)  12/115 (10.43%) 
Constipation  1  18/113 (15.93%)  14/115 (12.17%) 
Nausea  1  14/113 (12.39%)  34/115 (29.57%) 
Vomiting  1  11/113 (9.73%)  14/115 (12.17%) 
Dyspepsia  1  9/113 (7.96%)  2/115 (1.74%) 
Abdominal pain  1  8/113 (7.08%)  6/115 (5.22%) 
Gastrooesophageal reflux disease  1  6/113 (5.31%)  3/115 (2.61%) 
General disorders     
Fatigue  1  20/113 (17.70%)  19/115 (16.52%) 
Pyrexia  1  19/113 (16.81%)  28/115 (24.35%) 
Oedema peripheral  1  14/113 (12.39%)  8/115 (6.96%) 
Asthenia  1  11/113 (9.73%)  17/115 (14.78%) 
Chills  1  6/113 (5.31%)  10/115 (8.70%) 
Peripheral swelling  1  6/113 (5.31%)  2/115 (1.74%) 
Infections and infestations     
Upper respiratory tract infection  1  15/113 (13.27%)  7/115 (6.09%) 
Nasopharyngitis  1  13/113 (11.50%)  4/115 (3.48%) 
Urinary tract infection  1  12/113 (10.62%)  7/115 (6.09%) 
Conjunctivitis  1  12/113 (10.62%)  2/115 (1.74%) 
Pneumonia  1  10/113 (8.85%)  5/115 (4.35%) 
Respiratory tract infection  1  6/113 (5.31%)  1/115 (0.87%) 
Oral herpes  1  0/113 (0.00%)  6/115 (5.22%) 
Bronchitis  1  8/113 (7.08%)  2/115 (1.74%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  26/113 (23.01%)  61/115 (53.04%) 
Fall  1  7/113 (6.19%)  3/115 (2.61%) 
Investigations     
Blood creatine increased  1  7/113 (6.19%)  1/115 (0.87%) 
Weight decreased  1  2/113 (1.77%)  6/115 (5.22%) 
Metabolism and nutrition disorders     
Hyperuricaemia  1  15/113 (13.27%)  0/115 (0.00%) 
Decreased appetite  1  7/113 (6.19%)  5/115 (4.35%) 
Iron deficiency  1  6/113 (5.31%)  0/115 (0.00%) 
Hyperglycaemia  1  6/113 (5.31%)  7/115 (6.09%) 
Hypokalaemia  1  7/113 (6.19%)  2/115 (1.74%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  25/113 (22.12%)  12/115 (10.43%) 
Back pain  1  20/113 (17.70%)  12/115 (10.43%) 
Muscle spasms  1  15/113 (13.27%)  7/115 (6.09%) 
Pain in extremity  1  11/113 (9.73%)  10/115 (8.70%) 
Myalgia  1  7/113 (6.19%)  4/115 (3.48%) 
Musculoskeletal pain  1  6/113 (5.31%)  3/115 (2.61%) 
Nervous system disorders     
Dizziness  1  11/113 (9.73%)  7/115 (6.09%) 
Headache  1  9/113 (7.96%)  13/115 (11.30%) 
Tremor  1  4/113 (3.54%)  7/115 (6.09%) 
Psychiatric disorders     
Insomnia  1  13/113 (11.50%)  5/115 (4.35%) 
Anxiety  1  9/113 (7.96%)  8/115 (6.96%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  30/113 (26.55%)  14/115 (12.17%) 
Dyspnoea  1  11/113 (9.73%)  16/115 (13.91%) 
Oropharyngeal pain  1  8/113 (7.08%)  4/115 (3.48%) 
Productive cough  1  7/113 (6.19%)  2/115 (1.74%) 
Epistaxis  1  6/113 (5.31%)  9/115 (7.83%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  17/113 (15.04%)  2/115 (1.74%) 
Rash  1  10/113 (8.85%)  1/115 (0.87%) 
Pruritus  1  9/113 (7.96%)  4/115 (3.48%) 
Dry Skin  1  7/113 (6.19%)  0/115 (0.00%) 
Ecchymosis  1  7/113 (6.19%)  0/115 (0.00%) 
Onychoclasis  1  6/113 (5.31%)  0/115 (0.00%) 
Vascular disorders     
Hypertension  1  19/113 (16.81%)  5/115 (4.35%) 
Hypotension  1  0/113 (0.00%)  6/115 (5.22%) 
1
Term from vocabulary, MedDRA Version 20.1
Indicates events were collected by 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.
  1. Institution/Investigator will not publish without Sponsor prior review and approval
  2. Institution/Investigator will not publish until the earlier of (i) results of study are submitted for publication (ii) notification that submission of the multicenter results are no longer planned (iii) 18 months after study termination.
Results Point of Contact
Name/Title: Lori Styles
Organization: Pharmacyclics LLC, An AbbVie Company
Phone: (408) 215-3770
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02264574     History of Changes
Other Study ID Numbers: PCYC-1130-CA
First Submitted: October 1, 2014
First Posted: October 15, 2014
Results First Submitted: March 25, 2019
Results First Posted: April 16, 2019
Last Update Posted: May 15, 2019