Trial Outcomes & Findings for Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease (NCT NCT02195869)
NCT ID: NCT02195869
Last Updated: 2019-07-11
Results Overview
Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
28 treatment days after last subject enrolled in Phase 1 dose level(s).
Results posted on
2019-07-11
Participant Flow
Participant milestones
| Measure |
Phase 1b/Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
All-Treated Population
|
42
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
Phase 1b/Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|
|
Overall Study
cGVHD Progression
|
5
|
|
Overall Study
Malignancy Progression/relapse
|
2
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Study Terminated by Sponsor
|
7
|
|
Overall Study
Noncompliance with study drug
|
2
|
Baseline Characteristics
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
Baseline characteristics by cohort
| Measure |
Phase 1b/Phase 2
n=42 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 15.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 treatment days after last subject enrolled in Phase 1 dose level(s).Population: Endpoint only includes Phase 1 data.
Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib
Outcome measures
| Measure |
Phase 1b: Dose Level 1
n=6 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
|
Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|---|
|
Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.Population: Efficacy analyses were performed using the All-treated Population (N = 42)
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).
Outcome measures
| Measure |
Phase 1b: Dose Level 1
n=42 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
|
Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|---|
|
Phase 2: Overall Response Rate as the Percentage of Participants With Response
|
69 percentage of participants
Interval 52.9 to 82.4
|
—
|
SECONDARY outcome
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.Population: 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.
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.
Outcome measures
| Measure |
Phase 1b: Dose Level 1
n=29 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
|
Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|---|
|
Sustained Response Rate as the Percentage of Participants With Sustained Response
|
69 percentage of participants
Interval 49.2 to 84.7
|
—
|
SECONDARY outcome
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.Population: Phase 2 subjects includes all subjects who participated in Phase 1b
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.
Outcome measures
| Measure |
Phase 1b: Dose Level 1
n=29 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
|
Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|---|
|
To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)
|
NA Median
NA means not achieved or not estimable.
|
—
|
SECONDARY outcome
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.Population: Phase 2 subjects includes all subjects who participated in Phase 1b.
Average daily corticosteroid dose assessed each week.
Outcome measures
| Measure |
Phase 1b: Dose Level 1
n=42 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
|
Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|---|
|
Corticosteroid Requirement Changes Over Time
Week 1
|
0.31 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.06 to 1.3
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 2
|
0.32 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.06 to 1.35
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 3
|
0.32 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.06 to 1.35
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 4
|
0.31 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.06 to 1.35
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 5
|
0.31 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.06 to 1.53
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 6
|
0.30 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.06 to 1.53
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 7
|
0.30 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.06 to 1.53
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 8
|
0.30 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.01 to 1.53
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 9
|
0.27 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 1.03
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 10
|
0.25 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 1.54
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 11
|
0.25 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 2.02
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 12
|
0.25 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.62
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 13
|
0.24 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.62
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 14
|
0.23 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.57
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 15
|
0.23 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.58
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 16
|
0.23 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.48
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 17
|
0.21 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.47
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 18
|
0.20 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.44
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 19
|
0.20 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.44
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 20
|
0.21 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.44
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 21
|
0.22 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.37
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 22
|
0.22 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.37
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 23
|
0.22 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.6
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 24
|
0.21 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.37
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 25
|
0.19 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.38
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 26
|
0.18 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.37
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 27
|
0.18 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.37
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 28
|
0.18 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.37
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 29
|
0.16 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.37
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 30
|
0.16 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.32
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 31
|
0.16 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.29
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 32
|
0.18 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.29
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 33
|
0.17 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.29
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 34
|
0.17 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.29
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 35
|
0.18 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.29
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 36
|
0.18 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.29
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 37
|
0.16 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.29
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 38
|
0.15 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.35
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 39
|
0.15 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.3
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 40
|
0.15 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.3
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 41
|
0.15 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.3
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 42
|
0.15 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.3
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 43
|
0.13 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.3
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 44
|
0.13 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 45
|
0.13 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 46
|
0.13 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.6
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 47
|
0.13 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.6
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 48
|
0.13 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.53
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 49
|
0.12 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.46
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 50
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.36
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 51
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.24
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 52
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.24
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 53
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.24
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 54
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.24
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 55
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.24
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 56
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.24
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 57
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.24
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 58
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 59
|
0.10 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.27
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 60
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 61
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 62
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 63
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 64
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 65
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 66
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 67
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 68
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 69
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 70
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 71
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 72
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 73
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 74
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.21
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 75
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.2
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 76
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.2
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 77
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.2
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 78
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.2
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 79
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.2
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 80
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.2
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 81
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.27
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 82
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.31
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 83
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.31
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 84
|
0.07 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.31
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 85
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.31
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 86
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.32
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 87
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.32
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 88
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.32
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 89
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 90
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 91
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 92
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 93
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 94
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 95
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 96
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 97
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 98
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 99
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 100
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 101
|
0.09 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 102
|
0.09 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 103
|
0.09 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 104
|
0.09 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 105
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 106
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 107
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 108
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 109
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 110
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 111
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 112
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 113
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 114
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 115
|
0.12 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 116
|
0.12 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 117
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 118
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 119
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 120
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 121
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 122
|
0.12 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.95
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 123
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 124
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 125
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 126
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 127
|
0.08 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 128
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 129
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 130
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.22
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 131
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.19
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 132
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 133
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 134
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 135
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 137
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 138
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 139
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 140
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 141
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.16
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 142
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 143
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 144
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 145
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 146
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 147
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 148
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 149
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 150
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 151
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 152
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.17
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 153
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 154
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.14
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 155
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.14
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 156
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.14
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 157
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.13
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 158
|
0.06 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.11
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 159
|
0.06 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.11
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 160
|
0.06 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.11
|
—
|
|
Corticosteroid Requirement Changes Over Time
Week 136
|
0.00 Daily Dose of Steroid by Weight (mg/kg/d
Interval 0.0 to 0.15
|
—
|
SECONDARY outcome
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.Population: All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose.
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.
Outcome measures
| Measure |
Phase 1b: Dose Level 1
n=42 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
|
Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|---|
|
Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score
|
42.9 percentage of participants
Interval 27.7 to 59.0
|
—
|
SECONDARY outcome
Timeframe: From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 monthsPopulation: Phase 2 subjects includes all subjects who participated in Phase 1b
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib
Outcome measures
| Measure |
Phase 1b: Dose Level 1
n=42 Participants
Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
|
Phase 2
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|---|
|
Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD
|
42 Participants
|
—
|
Adverse Events
Phase1b/Phase 2
Serious events: 22 serious events
Other events: 41 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Phase1b/Phase 2
n=42 participants at risk
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
14.3%
6/42 • 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 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)
|
|
Infections and infestations
Cellulitis
|
4.8%
2/42 • 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 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)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
2/42 • 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 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)
|
|
Nervous system disorders
Headache
|
4.8%
2/42 • 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 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)
|
|
Infections and infestations
Septic shock
|
4.8%
2/42 • 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 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
2.4%
1/42 • 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 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)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/42 • 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 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)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • 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 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)
|
|
Cardiac disorders
Atrial fibrilation
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Bacteraemia
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Brain abscess
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Clostridium difficile infection
|
2.4%
1/42 • 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 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)
|
|
Injury, poisoning and procedural complications
Compression fracture
|
2.4%
1/42 • 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 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)
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
1/42 • 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 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)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/42 • 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 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)
|
|
Investigations
Electrocardiogram QT prolonged
|
2.4%
1/42 • 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 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)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.4%
1/42 • 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 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)
|
|
Immune system disorders
Graft versus host disease
|
2.4%
1/42 • 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 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)
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • 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 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)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42 • 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 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)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • 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 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)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Pneumonia viral
|
2.4%
1/42 • 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 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)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/42 • 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 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prolymphocytic leukaemia
|
2.4%
1/42 • 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 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)
|
|
General disorders
Pyrexia
|
2.4%
1/42 • 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 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)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Rhinovirus infection
|
2.4%
1/42 • 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 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)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.4%
1/42 • 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 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)
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • 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 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)
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/42 • 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 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)
|
Other adverse events
| Measure |
Phase1b/Phase 2
n=42 participants at risk
Subjects receive daily dose of 420 mg of Ibrutinib capsules
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
40.5%
17/42 • 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 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)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
23.8%
10/42 • 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 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)
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
3/42 • 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 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)
|
|
Cardiac disorders
Cardiac Disorders
|
26.2%
11/42 • 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 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)
|
|
Cardiac disorders
Sinus tachycardia
|
9.5%
4/42 • 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 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)
|
|
Cardiac disorders
Tachycardia
|
7.1%
3/42 • 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 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)
|
|
Eye disorders
Eye disorders
|
26.2%
11/42 • 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 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)
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
90.5%
38/42 • 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 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)
|
|
Gastrointestinal disorders
Diarrhoea
|
40.5%
17/42 • 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 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)
|
|
Gastrointestinal disorders
Nausea
|
28.6%
12/42 • 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 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)
|
|
Gastrointestinal disorders
Constipation
|
11.9%
5/42 • 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 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)
|
|
Gastrointestinal disorders
Mouth Ulceration
|
11.9%
5/42 • 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 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)
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
5/42 • 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 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)
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.5%
4/42 • 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 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)
|
|
Gastrointestinal disorders
Dry mouth
|
9.5%
4/42 • 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 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)
|
|
Gastrointestinal disorders
Gastroesophogeal reflux disease
|
9.5%
4/42 • 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 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)
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
3/42 • 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 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)
|
|
Gastrointestinal disorders
Oral pain
|
7.1%
3/42 • 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 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)
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
3/42 • 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 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)
|
|
General disorders
General disorders and administration site conditions
|
71.4%
30/42 • 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 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)
|
|
General disorders
Fatique
|
57.1%
24/42 • 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 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)
|
|
General disorders
Pyrexia
|
16.7%
7/42 • 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 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)
|
|
General disorders
Oedema peripheral
|
14.3%
6/42 • 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 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)
|
|
General disorders
Influenza like illness
|
7.1%
3/42 • 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 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)
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
9.5%
4/42 • 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 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)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
9.5%
4/42 • 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 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)
|
|
Immune system disorders
Immune system disorders
|
14.3%
6/42 • 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 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)
|
|
Infections and infestations
Infections and infestations
|
59.5%
25/42 • 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 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)
|
|
Infections and infestations
Upper respiratory tract infection
|
19.0%
8/42 • 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 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)
|
|
Infections and infestations
Cellulitis
|
9.5%
4/42 • 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 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)
|
|
Infections and infestations
Cytomegalovirus infection
|
7.1%
3/42 • 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 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)
|
|
Infections and infestations
Urinary tract infections
|
7.1%
3/42 • 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 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)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
33.3%
14/42 • 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 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)
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
7/42 • 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 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)
|
|
Injury, poisoning and procedural complications
Contusion
|
11.9%
5/42 • 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 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)
|
|
Injury, poisoning and procedural complications
Laceration
|
7.1%
3/42 • 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 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)
|
|
Investigations
Investigations
|
23.8%
10/42 • 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 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)
|
|
Investigations
Weight decreased
|
9.5%
4/42 • 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 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)
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
38.1%
16/42 • 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 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)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.9%
5/42 • 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 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)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.9%
5/42 • 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 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)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.9%
5/42 • 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 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)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.5%
4/42 • 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 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)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
47.6%
20/42 • 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 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)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
14/42 • 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 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)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
4/42 • 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 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)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • 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 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant unspecified (incl cysts and polyps)
|
9.5%
4/42 • 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 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)
|
|
Nervous system disorders
Nervous system disorders
|
40.5%
17/42 • 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 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)
|
|
Nervous system disorders
Headache
|
16.7%
7/42 • 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 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)
|
|
Nervous system disorders
Dizziness
|
9.5%
4/42 • 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 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)
|
|
Nervous system disorders
Somnolence
|
7.1%
3/42 • 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 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)
|
|
Psychiatric disorders
Psychiatric disorders
|
28.6%
12/42 • 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 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)
|
|
Psychiatric disorders
Anxiety
|
9.5%
4/42 • 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 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)
|
|
Psychiatric disorders
Delerium
|
7.1%
3/42 • 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 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)
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • 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 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)
|
|
Renal and urinary disorders
Renal and urinary disorders
|
11.9%
5/42 • 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 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)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
42.9%
18/42 • 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 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)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
7/42 • 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 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)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
6/42 • 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 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)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
45.2%
19/42 • 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 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)
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
7.1%
3/42 • 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 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)
|
|
Vascular disorders
Vascular disorders
|
21.4%
9/42 • 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 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)
|
|
Vascular disorders
Hypertension
|
7.1%
3/42 • 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 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)
|
|
Vascular disorders
Hypotension
|
7.1%
3/42 • 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 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)
|
Additional Information
Manuela Juretic, Associate Director, Clinical Operations
Pharmacyclics LLC, An AbbVie Company
Phone: (408) 215.3628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/Investigator will not publish without Sponsor prior review and approval.
- Publication restrictions are in place
Restriction type: OTHER