Trial · NCT02195869
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
NCT02195869, Phase 1, Phase 2, Completed, Pharmacyclics LLC.; results first posted 2019-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease. Trials, record NCT02195869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02195869
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
- NCT number
- NCT02195869
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Graft Versus Host Disease
- Interventions
- Ibrutinib
- First posted
- 2014-07-21
- Last updated
- 2019-07-11
- Results first posted
- 2019-07-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. | 28 treatment days after last subject enrolled in Phase 1 dose level(s). | Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib |
| Primary | Phase 2: Overall Response Rate as the Percentage of Participants With Response | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | 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). |
| Secondary | Sustained Response Rate as the Percentage of Participants With Sustained Response | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | 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. |
| Secondary | To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR) | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | 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. |
| Secondary | Corticosteroid Requirement Changes Over Time | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | Average daily corticosteroid dose assessed each week. |
| Secondary | Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | 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. |
| Secondary | Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD | From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months | Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. | 28 treatment days after last subject enrolled in Phase 1 dose level(s). | Endpoint only includes Phase 1 data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Response Rate as the Percentage of Participants With Response | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | Efficacy analyses were performed using the All-treated Population (N = 42) | percentage of participants | NUMBER |
| SECONDARY | Sustained Response Rate as the Percentage of Participants With Sustained Response | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | 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. | percentage of participants | NUMBER |
| SECONDARY | To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR) | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | Phase 2 subjects includes all subjects who participated in Phase 1b | Median | MEDIAN |
| SECONDARY | Corticosteroid Requirement Changes Over Time | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | Phase 2 subjects includes all subjects who participated in Phase 1b. | Daily Dose of Steroid by Weight (mg/kg/d | MEDIAN |
| SECONDARY | Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. | All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose. | percentage of participants | NUMBER |
| SECONDARY | Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD | From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months | Phase 2 subjects includes all subjects who participated in Phase 1b | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group166
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. | Phase 1b: Dose Level 1 | 0 | Participants | ||
| Phase 2: Overall Response Rate as the Percentage of Participants With Response | Phase1b/Phase 2 | 69 | 95% Confidence Interval 52.9 to 82.4 | percentage of participants | |
| Sustained Response Rate as the Percentage of Participants With Sustained Response | Phase1b/Phase 2 | 69 | 95% Confidence Interval 49.2 to 84.7 | percentage of participants | |
| To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR) | Phase1b/Phase 2 | NA | 95% Confidence Interval NA to NA | Median | |
| Corticosteroid Requirement Changes Over Time | Phase 1b/Phase 2 | Week 1 | 0.31 | Full Range 0.06 to 1.3 | Daily Dose of Steroid by Weight (mg/kg/d |
| Corticosteroid Requirement Changes Over Time | Phase 1b/Phase 2 | Week 2 | 0.32 | Full Range 0.06 to 1.35 | Daily Dose of Steroid by Weight (mg/kg/d |
| Corticosteroid Requirement Changes Over Time | Phase 1b/Phase 2 | Week 3 | 0.32 | Full Range 0.06 to 1.35 | Daily Dose of Steroid by Weight (mg/kg/d |
| Corticosteroid Requirement Changes Over Time | Phase 1b/Phase 2 | Week 4 | 0.31 | Full Range 0.06 to 1.35 | Daily Dose of Steroid by Weight (mg/kg/d |
| Corticosteroid Requirement Changes Over Time | Phase 1b/Phase 2 | Week 5 | 0.31 | Full Range 0.06 to 1.53 | Daily Dose of Steroid by Weight (mg/kg/d |
| Corticosteroid Requirement Changes Over Time | Phase 1b/Phase 2 | Week 6 | 0.30 | Full Range 0.06 to 1.53 | Daily Dose of Steroid by Weight (mg/kg/d |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b/Phase 2 | 42 | |
| Overall Study | All-Treated Population | Phase 1b/Phase 2 | 42 | |
| Overall Study | COMPLETED | Phase 1b/Phase 2 | 0 | |
| Overall Study | NOT COMPLETED | Phase 1b/Phase 2 | 42 |
Source ClinicalTrials.gov
Adverse events98
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Phase1b/Phase 2 | 17 | 42 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Phase1b/Phase 2 | 10 | 42 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase1b/Phase 2 | 3 | 42 | |
| other | Cardiac Disorders | Cardiac disorders | Phase1b/Phase 2 | 11 | 42 | |
| other | Sinus tachycardia | Cardiac disorders | Phase1b/Phase 2 | 4 | 42 | |
| other | Tachycardia | Cardiac disorders | Phase1b/Phase 2 | 3 | 42 | |
| other | Eye disorders | Eye disorders | Phase1b/Phase 2 | 11 | 42 | |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Phase1b/Phase 2 | 38 | 42 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase1b/Phase 2 | 17 | 42 | |
| other | Nausea | Gastrointestinal disorders | Phase1b/Phase 2 | 12 | 42 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase1b/Phase 2 | 7 | 42 |
| Total, other adverse events | Phase1b/Phase 2 | 41 | 42 |
| Total, serious adverse events | Phase1b/Phase 2 | 22 | 42 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02195869
GET https://conductscience.org/api/trials/v1/NCT02195869/results?page=2