Trial · NCT02959944
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
NCT02959944, Phase 3, Completed, Pharmacyclics LLC.; results first posted 2021-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD). Trials, record NCT02959944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02959944
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
- NCT number
- NCT02959944
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 193 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Chronic Graft Versus Host Disease
- Interventions
- ibrutinib, Placebo, Prednisone
- First posted
- 2016-11-09
- Last updated
- 2023-03-30
- Results first posted
- 2021-05-04
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Analysis: Response Rate at 48 Weeks | 48 weeks (Cumulatively up to 30 March 2020) | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. |
| Primary | Final Analysis: Response Rate at 48 Weeks | 48 weeks (Cumulatively up to 12 July 2021) | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. |
| Secondary | Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020) | The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval \[CI\]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. |
| Secondary | Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) | The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval \[CI\]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. |
| Secondary | Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | Months 3, 6, 9, 12, 15, 18, 21, 24 (cumulatively up to 30 March 2020) | The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. |
| Secondary | Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) | The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. |
| Secondary | Primary Analysis: Response Rate at 24 Weeks | 24 weeks (Cumulatively up to 30 March 2020) | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. |
| Secondary | Final Analysis: Response Rate at 24 Weeks | 24 weeks (Cumulatively up to 12 July 2021) | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. |
| Secondary | Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020) | Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment. The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. 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. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. |
| Secondary | Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021) | Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment. The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. 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. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Analysis: Response Rate at 48 Weeks | 48 weeks (Cumulatively up to 30 March 2020) | Intent to Treat Population: all randomized participants. | percentage of participants | NUMBER |
| PRIMARY | Final Analysis: Response Rate at 48 Weeks | 48 weeks (Cumulatively up to 12 July 2021) | Intent to Treat Population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020) | Intent to Treat Population: all randomized participants. Participants with withdrawal of all corticosteroids. No participants were on corticosteroids at 21 and 24 Months in the Ibrutinib + Prednisone Arm/Group. | proportion of participants | NUMBER |
| SECONDARY | Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) | Intent to Treat Population: all randomized participants. Participants with withdrawal of all corticosteroids. No participants were on corticosteroids at 21 and 24 Months in the Ibrutinib + Prednisone Arm/Group. | proportion of participants | NUMBER |
| SECONDARY | Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | Months 3, 6, 9, 12, 15, 18, 21, 24 (cumulatively up to 30 March 2020) | Intent to Treat Population: all randomized participants. Participants with withdrawal of all immunosuppressants | proportion of participants | NUMBER |
| SECONDARY | Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) | Intent to Treat Population: all randomized participants. Participants with withdrawal of all immunosuppressants | proportion of participants | NUMBER |
| SECONDARY | Primary Analysis: Response Rate at 24 Weeks | 24 weeks (Cumulatively up to 30 March 2020) | Intent to Treat Population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Final Analysis: Response Rate at 24 Weeks | 24 weeks (Cumulatively up to 12 July 2021) | Intent to Treat Population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020) | Intent to Treat Population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021) | Intent to Treat Population: all randomized participants. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group146
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Analysis: Response Rate at 48 Weeks | Ibrutinib + Prednisone | 41.1 | percentage of participants | ||
| Primary Analysis: Response Rate at 48 Weeks | Placebo + Prednisone | 36.7 | percentage of participants | ||
| Final Analysis: Response Rate at 48 Weeks | Ibrutinib + Prednisone | 41.1 | percentage of participants | ||
| Final Analysis: Response Rate at 48 Weeks | Placebo + Prednisone | 36.7 | percentage of participants | ||
| Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Ibrutinib + Prednisone | 3 Months | 0.042 | 95% Confidence Interval 0.014 to 0.097 | proportion of participants |
| Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Placebo + Prednisone | 3 Months | 0.021 | 95% Confidence Interval 0.004 to 0.066 | proportion of participants |
| Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Ibrutinib + Prednisone | 6 Months | 0.229 | 95% Confidence Interval 0.149 to 0.320 | proportion of participants |
| Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Placebo + Prednisone | 6 Months | 0.216 | 95% Confidence Interval 0.140 to 0.304 | proportion of participants |
| Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Ibrutinib + Prednisone | 9 Months | 0.318 | 95% Confidence Interval 0.225 to 0.415 | proportion of participants |
| Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | Placebo + Prednisone | 9 Months | 0.322 | 95% Confidence Interval 0.231 to 0.417 | proportion of participants |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrutinib + Prednisone | 95 | |
| Overall Study | STARTED | Placebo + Prednisone | 98 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Ibrutinib + Prednisone | 94 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo + Prednisone | 96 | |
| Overall Study | COMPLETED | Ibrutinib + Prednisone | 95 | |
| Overall Study | COMPLETED | Placebo + Prednisone | 98 | |
| Overall Study | NOT COMPLETED | Ibrutinib + Prednisone | 0 | |
| Overall Study | NOT COMPLETED | Placebo + Prednisone | 0 |
Source ClinicalTrials.gov
Adverse events396
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 | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Ibrutinib | 9 | 94 | 10 |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Placebo | 8 | 96 | 8 |
| other | ANAEMIA | Blood and lymphatic system disorders | Ibrutinib | 4 | 94 | 17 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo | 11 | 96 | 21 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Ibrutinib | 1 | 94 | 1 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo | 6 | 96 | 11 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Ibrutinib | 18 | 94 | 30 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Placebo | 15 | 96 | 25 |
| other | PALPITATIONS | Cardiac disorders | Ibrutinib | 5 | 94 | 5 |
| other | PALPITATIONS | Cardiac disorders | Placebo | 3 | 96 | 3 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib | 23 | 94 |
| Total, all-cause mortality | Placebo | 22 | 96 |
| Total, other adverse events | Ibrutinib | 88 | 94 |
| Total, other adverse events | Placebo | 92 | 96 |
| Total, serious adverse events | Ibrutinib | 51 | 94 |
| Total, serious adverse events | Placebo | 49 | 96 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36608310 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ibrutinib vs Placebo: deaths from any cause | Trial comparisons |
| Ibrutinib vs Placebo: serious adverse events | Trial comparisons |
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/NCT02959944
GET https://conductscience.org/api/trials/v1/NCT02959944/results?page=2