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Trial record 1 of 1 for:    PCYC-1129 | Graft-versus-host-disease
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Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease

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ClinicalTrials.gov Identifier: NCT02195869
Recruitment Status : Completed
First Posted : July 21, 2014
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Graft Versus Host Disease
Intervention Drug: Ibrutinib
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1b/Phase 2
Hide Arm/Group Description Subjects receive daily dose of 420 mg of Ibrutinib capsules
Period Title: Overall Study
Started 42 [1]
All-Treated Population 42
Completed 0
Not Completed 42
Reason Not Completed
cGVHD Progression             5
Malignancy Progression/relapse             2
Adverse Event             15
Withdrawal by Subject             7
Physician Decision             4
Study Terminated by Sponsor             7
Noncompliance with study drug             2
[1]
Phase 1b: 6 patients, 420 mg, no DLT observed. Phase 2: 42 patients, 420 mg
Arm/Group Title Phase 1b/Phase 2
Hide Arm/Group Description Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
Baseline analysis population includes all participants that received at least 1 dose of ibrutinib.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
35
  83.3%
>=65 years
7
  16.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
50.5  (15.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
20
  47.6%
Male
22
  52.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Hispanic or Latino
2
   4.8%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
40
  95.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.4%
White
39
  92.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
1.Primary Outcome
Title Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.
Hide Description Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib
Time Frame 28 treatment days after last subject enrolled in Phase 1 dose level(s).
Hide Outcome Measure Data
Hide Analysis Population Description
Endpoint only includes Phase 1 data.
Arm/Group Title Phase 1b: Dose Level 1 Phase 2
Hide Arm/Group Description:
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Participants Analyzed 6 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Phase 2: Overall Response Rate as the Percentage of Participants With Response
Hide Description Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site).
Time Frame Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed using the All-treated Population (N = 42)
Arm/Group Title Phase1b/Phase 2
Hide Arm/Group Description:
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69
(52.9 to 82.4)
3.Secondary Outcome
Title Sustained Response Rate as the Percentage of Participants With Sustained Response
Hide Description For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable.
Time Frame Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 subjects include all subjects who participated in phase 1b. Subjects evaluated for sustained response includes participants who had achieved an NIH-defined CR or PR.
Arm/Group Title Phase1b/Phase 2
Hide Arm/Group Description:
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69
(49.2 to 84.7)
4.Secondary Outcome
Title To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)
Hide Description For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable.
Time Frame Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 subjects includes all subjects who participated in Phase 1b
Arm/Group Title Phase1b/Phase 2
Hide Arm/Group Description:
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: Median
NA [1] 
(NA to NA)
[1]
NA means not achieved or not estimable.
5.Secondary Outcome
Title Corticosteroid Requirement Changes Over Time
Hide Description Average daily corticosteroid dose assessed each week.
Time Frame Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 subjects includes all subjects who participated in Phase 1b.
Arm/Group Title Phase 1b/Phase 2
Hide Arm/Group Description:
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Participants Analyzed 42
Median (Full Range)
Unit of Measure: Daily Dose of Steroid by Weight (mg/kg/d
Week 1 Number Analyzed 42 participants
0.31
(0.06 to 1.3)
Week 2 Number Analyzed 42 participants
0.32
(0.06 to 1.35)
Week 3 Number Analyzed 42 participants
0.32
(0.06 to 1.35)
Week 4 Number Analyzed 41 participants
0.31
(0.06 to 1.35)
Week 5 Number Analyzed 41 participants
0.31
(0.06 to 1.53)
Week 6 Number Analyzed 41 participants
0.30
(0.06 to 1.53)
Week 7 Number Analyzed 41 participants
0.30
(0.06 to 1.53)
Week 8 Number Analyzed 39 participants
0.30
(0.01 to 1.53)
Week 9 Number Analyzed 37 participants
0.27
(0.00 to 1.03)
Week 10 Number Analyzed 36 participants
0.25
(0.00 to 1.54)
Week 11 Number Analyzed 33 participants
0.25
(0.00 to 2.02)
Week 12 Number Analyzed 30 participants
0.25
(0.00 to 0.62)
Week 13 Number Analyzed 29 participants
0.24
(0.00 to 0.62)
Week 14 Number Analyzed 28 participants
0.23
(0.00 to 0.57)
Week 15 Number Analyzed 28 participants
0.23
(0.00 to 0.58)
Week 16 Number Analyzed 27 participants
0.23
(0.00 to 0.48)
Week 17 Number Analyzed 26 participants
0.21
(0.00 to 0.47)
Week 18 Number Analyzed 26 participants
0.20
(0.00 to 0.44)
Week 19 Number Analyzed 26 participants
0.20
(0.00 to 0.44)
Week 20 Number Analyzed 26 participants
0.21
(0.00 to 0.44)
Week 21 Number Analyzed 26 participants
0.22
(0.00 to 0.37)
Week 22 Number Analyzed 26 participants
0.22
(0.00 to 0.37)
Week 23 Number Analyzed 26 participants
0.22
(0.00 to 0.60)
Week 24 Number Analyzed 26 participants
0.21
(0.00 to 0.37)
Week 25 Number Analyzed 26 participants
0.19
(0.00 to 0.38)
Week 26 Number Analyzed 23 participants
0.18
(0.00 to 0.37)
Week 27 Number Analyzed 23 participants
0.18
(0.00 to 0.37)
Week 28 Number Analyzed 23 participants
0.18
(0.00 to 0.37)
Week 29 Number Analyzed 23 participants
0.16
(0.00 to 0.37)
Week 30 Number Analyzed 23 participants
0.16
(0.00 to 0.32)
Week 31 Number Analyzed 23 participants
0.16
(0.00 to 0.29)
Week 32 Number Analyzed 22 participants
0.18
(0.00 to 0.29)
Week 33 Number Analyzed 22 participants
0.17
(0.00 to 0.29)
Week 34 Number Analyzed 22 participants
0.17
(0.00 to 0.29)
Week 35 Number Analyzed 21 participants
0.18
(0.00 to 0.29)
Week 36 Number Analyzed 21 participants
0.18
(0.00 to 0.29)
Week 37 Number Analyzed 21 participants
0.16
(0.00 to 0.29)
Week 38 Number Analyzed 21 participants
0.15
(0.00 to 0.35)
Week 39 Number Analyzed 20 participants
0.15
(0.00 to 0.30)
Week 40 Number Analyzed 20 participants
0.15
(0.00 to 0.30)
Week 41 Number Analyzed 20 participants
0.15
(0.00 to 0.30)
Week 42 Number Analyzed 20 participants
0.15
(0.00 to 0.30)
Week 43 Number Analyzed 20 participants
0.13
(0.00 to 0.30)
Week 44 Number Analyzed 20 participants
0.13
(0.00 to 0.21)
Week 45 Number Analyzed 20 participants
0.13
(0.00 to 0.21)
Week 46 Number Analyzed 19 participants
0.13
(0.00 to 0.60)
Week 47 Number Analyzed 19 participants
0.13
(0.00 to 0.60)
Week 48 Number Analyzed 19 participants
0.13
(0.00 to 0.53)
Week 49 Number Analyzed 19 participants
0.12
(0.00 to 0.46)
Week 50 Number Analyzed 19 participants
0.10
(0.00 to 0.36)
Week 51 Number Analyzed 19 participants
0.10
(0.00 to 0.24)
Week 52 Number Analyzed 19 participants
0.10
(0.00 to 0.24)
Week 53 Number Analyzed 19 participants
0.10
(0.00 to 0.24)
Week 54 Number Analyzed 19 participants
0.10
(0.00 to 0.24)
Week 55 Number Analyzed 19 participants
0.10
(0.00 to 0.24)
Week 56 Number Analyzed 19 participants
0.10
(0.00 to 0.24)
Week 57 Number Analyzed 19 participants
0.10
(0.00 to 0.24)
Week 58 Number Analyzed 18 participants
0.10
(0.00 to 0.21)
Week 59 Number Analyzed 18 participants
0.10
(0.00 to 0.27)
Week 60 Number Analyzed 18 participants
0.08
(0.00 to 0.21)
Week 61 Number Analyzed 18 participants
0.08
(0.00 to 0.21)
Week 62 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 63 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 64 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 65 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 66 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 67 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 68 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 69 Number Analyzed 16 participants
0.08
(0.00 to 0.21)
Week 70 Number Analyzed 15 participants
0.08
(0.00 to 0.21)
Week 71 Number Analyzed 15 participants
0.07
(0.00 to 0.21)
Week 72 Number Analyzed 15 participants
0.08
(0.00 to 0.21)
Week 73 Number Analyzed 15 participants
0.08
(0.00 to 0.21)
Week 74 Number Analyzed 14 participants
0.07
(0.00 to 0.21)
Week 75 Number Analyzed 14 participants
0.07
(0.00 to 0.20)
Week 76 Number Analyzed 14 participants
0.07
(0.00 to 0.20)
Week 77 Number Analyzed 14 participants
0.07
(0.00 to 0.20)
Week 78 Number Analyzed 14 participants
0.07
(0.00 to 0.20)
Week 79 Number Analyzed 14 participants
0.07
(0.00 to 0.20)
Week 80 Number Analyzed 14 participants
0.07
(0.00 to 0.20)
Week 81 Number Analyzed 14 participants
0.07
(0.00 to 0.27)
Week 82 Number Analyzed 14 participants
0.07
(0.00 to 0.31)
Week 83 Number Analyzed 14 participants
0.07
(0.00 to 0.31)
Week 84 Number Analyzed 13 participants
0.07
(0.00 to 0.31)
Week 85 Number Analyzed 12 participants
0.08
(0.00 to 0.31)
Week 86 Number Analyzed 12 participants
0.08
(0.00 to 0.32)
Week 87 Number Analyzed 12 participants
0.08
(0.00 to 0.32)
Week 88 Number Analyzed 12 participants
0.08
(0.00 to 0.32)
Week 89 Number Analyzed 12 participants
0.08
(0.00 to 0.95)
Week 90 Number Analyzed 12 participants
0.08
(0.00 to 0.95)
Week 91 Number Analyzed 12 participants
0.08
(0.00 to 0.95)
Week 92 Number Analyzed 12 participants
0.08
(0.00 to 0.95)
Week 93 Number Analyzed 12 participants
0.08
(0.00 to 0.95)
Week 94 Number Analyzed 12 participants
0.08
(0.00 to 0.95)
Week 95 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 96 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 97 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 98 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 99 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 100 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 101 Number Analyzed 11 participants
0.09
(0.00 to 0.95)
Week 102 Number Analyzed 11 participants
0.09
(0.00 to 0.95)
Week 103 Number Analyzed 11 participants
0.09
(0.00 to 0.95)
Week 104 Number Analyzed 11 participants
0.09
(0.00 to 0.95)
Week 105 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 106 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 107 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 108 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 109 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 110 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 111 Number Analyzed 11 participants
0.08
(0.00 to 0.95)
Week 112 Number Analyzed 9 participants
0.08
(0.00 to 0.95)
Week 113 Number Analyzed 8 participants
0.08
(0.00 to 0.95)
Week 114 Number Analyzed 8 participants
0.08
(0.00 to 0.95)
Week 115 Number Analyzed 8 participants
0.12
(0.00 to 0.95)
Week 116 Number Analyzed 8 participants
0.12
(0.00 to 0.95)
Week 117 Number Analyzed 7 participants
0.08
(0.00 to 0.95)
Week 118 Number Analyzed 7 participants
0.08
(0.00 to 0.95)
Week 119 Number Analyzed 7 participants
0.08
(0.00 to 0.95)
Week 120 Number Analyzed 7 participants
0.08
(0.00 to 0.95)
Week 121 Number Analyzed 7 participants
0.08
(0.00 to 0.95)
Week 122 Number Analyzed 6 participants
0.12
(0.00 to 0.95)
Week 123 Number Analyzed 5 participants
0.08
(0.00 to 0.22)
Week 124 Number Analyzed 5 participants
0.08
(0.00 to 0.22)
Week 125 Number Analyzed 5 participants
0.08
(0.00 to 0.22)
Week 126 Number Analyzed 4 participants
0.08
(0.00 to 0.22)
Week 127 Number Analyzed 4 participants
0.08
(0.00 to 0.22)
Week 128 Number Analyzed 3 participants
0.00
(0.00 to 0.22)
Week 129 Number Analyzed 3 participants
0.00
(0.00 to 0.22)
Week 130 Number Analyzed 3 participants
0.00
(0.00 to 0.22)
Week 131 Number Analyzed 3 participants
0.00
(0.00 to 0.19)
Week 132 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 133 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 134 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 135 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 136 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 137 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 138 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 139 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 140 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 141 Number Analyzed 3 participants
0.00
(0.00 to 0.16)
Week 142 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 143 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 144 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 145 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 146 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 147 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 148 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 149 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 150 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 151 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 152 Number Analyzed 3 participants
0.00
(0.00 to 0.17)
Week 153 Number Analyzed 3 participants
0.00
(0.00 to 0.15)
Week 154 Number Analyzed 3 participants
0.00
(0.00 to 0.14)
Week 155 Number Analyzed 3 participants
0.00
(0.00 to 0.14)
Week 156 Number Analyzed 3 participants
0.00
(0.00 to 0.14)
Week 157 Number Analyzed 3 participants
0.00
(0.00 to 0.13)
Week 158 Number Analyzed 2 participants
0.06
(0.00 to 0.11)
Week 159 Number Analyzed 2 participants
0.06
(0.00 to 0.11)
Week 160 Number Analyzed 2 participants
0.06
(0.00 to 0.11)
6.Secondary Outcome
Title Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score
Hide Description

Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in >7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life.

A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores.

There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome.

Time Frame Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose.
Arm/Group Title Phase 1b/Phase 2
Hide Arm/Group Description:
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.9
(27.7 to 59)
7.Secondary Outcome
Title Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD
Hide Description Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib
Time Frame From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 subjects includes all subjects who participated in Phase 1b
Arm/Group Title Phase 1b/Phase 2
Hide Arm/Group Description:
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Overall Number of Participants Analyzed 42
Measure Type: Count of Participants
Unit of Measure: Participants
42
 100.0%
Time Frame From first dose of study drug to within 30 days of last dose or starting subsequent therapy for cGVHD, up to 36.7 months
Adverse Event Reporting Description Adverse events were not collected by phase because the phase 1 part of the study confirmed the first dose level (420mg was acceptable for cGVHD subjects and it was used as the recommended Phase 2 dose (RP2D). The Safety Population was the same as the All-treated Population (ie, all subject who received at least 1 dose of ibrutinib at the RP2D)
 
Arm/Group Title Phase1b/Phase 2
Hide Arm/Group Description Subjects receive daily dose of 420 mg of Ibrutinib capsules
All-Cause Mortality
Phase1b/Phase 2
Affected / at Risk (%)
Total   7/42 (16.67%) 
Hide Serious Adverse Events
Phase1b/Phase 2
Affected / at Risk (%)
Total   22/42 (52.38%) 
Blood and lymphatic system disorders   
Anaemia  1  1/42 (2.38%) 
Cardiac disorders   
Atrial fibrilation  1  1/42 (2.38%) 
Gastrointestinal disorders   
Diarrhoea  1  1/42 (2.38%) 
General disorders   
Pyrexia  1  1/42 (2.38%) 
Immune system disorders   
Graft versus host disease  1  1/42 (2.38%) 
Infections and infestations   
Cellulitis  1  2/42 (4.76%) 
Septic shock  1  2/42 (4.76%) 
Bacteraemia  1  1/42 (2.38%) 
Brain abscess  1  1/42 (2.38%) 
Bronchopulmonary aspergillosis  1  1/42 (2.38%) 
Clostridium difficile infection  1  1/42 (2.38%) 
Pneumonia viral  1  1/42 (2.38%) 
Rhinovirus infection  1  1/42 (2.38%) 
Staphylococcal bacteraemia  1  1/42 (2.38%) 
Urinary tract infection  1  1/42 (2.38%) 
Injury, poisoning and procedural complications   
Compression fracture  1  1/42 (2.38%) 
Femur fracture  1  1/42 (2.38%) 
Investigations   
Electrocardiogram QT prolonged  1  1/42 (2.38%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/42 (2.38%) 
Muscular weakness  1  1/42 (2.38%) 
Myalgia  1  1/42 (2.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute lymphocytic leukaemia  1  1/42 (2.38%) 
Prolymphocytic leukaemia  1  1/42 (2.38%) 
Nervous system disorders   
Headache  1  2/42 (4.76%) 
Syncope  1  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  6/42 (14.29%) 
Dyspnoea  1  2/42 (4.76%) 
Pneumothorax  1  1/42 (2.38%) 
Respiratory failure  1  1/42 (2.38%) 
Skin and subcutaneous tissue disorders   
Pain of skin  1  1/42 (2.38%) 
Skin mass  1  1/42 (2.38%) 
Vascular disorders   
Deep vein thrombosis  1  1/42 (2.38%) 
Hypertension  1  1/42 (2.38%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase1b/Phase 2
Affected / at Risk (%)
Total   41/42 (97.62%) 
Blood and lymphatic system disorders   
Blood and lymphatic system disorders  1  17/42 (40.48%) 
Increased tendency to bruise  1  10/42 (23.81%) 
Anaemia  1  3/42 (7.14%) 
Cardiac disorders   
Cardiac Disorders  1  11/42 (26.19%) 
Sinus tachycardia  1  4/42 (9.52%) 
Tachycardia  1  3/42 (7.14%) 
Eye disorders   
Eye disorders  1  11/42 (26.19%) 
Gastrointestinal disorders   
Gastrointestinal disorders  1  38/42 (90.48%) 
Diarrhoea  1  17/42 (40.48%) 
Nausea  1  12/42 (28.57%) 
Constipation  1  5/42 (11.90%) 
Mouth Ulceration  1  5/42 (11.90%) 
Vomiting  1  5/42 (11.90%) 
Abdominal Pain  1  4/42 (9.52%) 
Dry mouth  1  4/42 (9.52%) 
Gastroesophogeal reflux disease  1  4/42 (9.52%) 
Dysphagia  1  3/42 (7.14%) 
Oral pain  1  3/42 (7.14%) 
Stomatitis  1  3/42 (7.14%) 
General disorders   
General disorders and administration site conditions  1  30/42 (71.43%) 
Fatique  1  24/42 (57.14%) 
Pyrexia  1  7/42 (16.67%) 
Oedema peripheral  1  6/42 (14.29%) 
Influenza like illness  1  3/42 (7.14%) 
Hepatobiliary disorders   
Hepatobiliary disorders  1  4/42 (9.52%) 
Hepatic function abnormal  1  4/42 (9.52%) 
Immune system disorders   
Immune system disorders  1  6/42 (14.29%) 
Infections and infestations   
Infections and infestations  1  25/42 (59.52%) 
Upper respiratory tract infection  1  8/42 (19.05%) 
Cellulitis  1  4/42 (9.52%) 
Cytomegalovirus infection  1  3/42 (7.14%) 
Urinary tract infections  1  3/42 (7.14%) 
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications  1  14/42 (33.33%) 
Fall  1  7/42 (16.67%) 
Contusion  1  5/42 (11.90%) 
Laceration  1  3/42 (7.14%) 
Investigations   
Investigations  1  10/42 (23.81%) 
Weight decreased  1  4/42 (9.52%) 
Metabolism and nutrition disorders   
Metabolism and nutrition disorders  1  16/42 (38.10%) 
Hyperglycaemia  1  5/42 (11.90%) 
Hypokalaemia  1  5/42 (11.90%) 
Hypophosphataemia  1  5/42 (11.90%) 
Decreased appetite  1  4/42 (9.52%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorders  1  20/42 (47.62%) 
Muscle spasms  1  14/42 (33.33%) 
Myalgia  1  4/42 (9.52%) 
Arthralgia  1  3/42 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant unspecified (incl cysts and polyps)  1  4/42 (9.52%) 
Nervous system disorders   
Nervous system disorders  1  17/42 (40.48%) 
Headache  1  7/42 (16.67%) 
Dizziness  1  4/42 (9.52%) 
Somnolence  1  3/42 (7.14%) 
Psychiatric disorders   
Psychiatric disorders  1  12/42 (28.57%) 
Anxiety  1  4/42 (9.52%) 
Delerium  1  3/42 (7.14%) 
Insomnia  1  3/42 (7.14%) 
Renal and urinary disorders   
Renal and urinary disorders  1  5/42 (11.90%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders  1  18/42 (42.86%) 
Dyspnoea  1  7/42 (16.67%) 
Cough  1  6/42 (14.29%) 
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders  1  19/42 (45.24%) 
Night Sweats  1  3/42 (7.14%) 
Vascular disorders   
Vascular disorders  1  9/42 (21.43%) 
Hypertension  1  3/42 (7.14%) 
Hypotension  1  3/42 (7.14%) 
1
Term from vocabulary, MedDRA 19.1
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.
Institution/Investigator will not publish without Sponsor prior review and approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manuela Juretic, Associate Director, Clinical Operations
Organization: Pharmacyclics LLC, An AbbVie Company
Phone: (408) 215.3628
EMail: mjuretic@pcyc.com
Layout table for additonal information
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02195869    
Other Study ID Numbers: PCYC-1129-CA
First Submitted: July 11, 2014
First Posted: July 21, 2014
Results First Submitted: April 30, 2019
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019