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NCT02959944 · ClinicalTrials.gov registry record · Phase 3
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
A Phase 3 study of Chronic Graft Versus Host Disease, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 3
- Development phase
- 193
- Enrollment target
- 20
- Study locations
NCT02959944: Completed Phase 3 study of Chronic Graft Versus Host Disease, sponsored by Pharmacyclics.
NCT02959944 is a Phase 3 study of Chronic Graft Versus Host Disease that has completed, run by Pharmacyclics. The registered enrollment target is 193 participants, above the 110-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (75% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02959944, a Phase 3 study of Chronic Graft Versus Host Disease, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 193 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Prednisone
- DRUG ibrutinib
Study Locations (20)
California
- LPCH Stanford /ID# 1140-1128 - Palo Alto
- Ucsf /Id# 1140-0003 - San Francisco
- Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400 - Stanford
Massachusetts
- Massachusetts General Hospital Cancer Center /ID# 1140-0020 - Boston
- Boston Childrens Hospital /ID# 1140-1615 - Boston
- Dana-Farber Cancer Institute /ID# 1140-0349 - Boston
Florida
- Jackson Memorial Hospital, University of Miami /ID# 1140-0647 - Miami
- Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121 - Orlando
Georgia
- Emory University, Winship Cancer Institute /ID# 1140-0033 - Atlanta
- Emory University/Winship Cancer Institute /ID# 1140-1179 - Atlanta
Illinois
- University of Chicago /ID# 1140-0126 - Chicago
- Loyola University /ID# 1140-0713 - Maywood
Kentucky
- University of Kentucky /ID# 1140-1140 - Lexington
- University of Louisville Hospital /ID# 1140-1131 - Louisville
Arizona
- Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120 - Scottsdale
Colorado
- UCHSC Anschultz Cancer Pavilion /ID# 1140-0068 - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2021-07-12 |
| Phase | Phase 3 |
What the finished NCT02959944 record still lists
NCT02959944 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, above the 110-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (75% higher).
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02959944 names 20 study sites across 12 states, led by California, Massachusetts, Florida.
Frequently Asked Questions
What is clinical trial NCT02959944 about?
NCT02959944 is a clinical study titled "Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)". To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
What is the current status of trial NCT02959944?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 193 participants. The study started on 2017-05-11. Estimated completion is 2021-07-12.
What conditions does trial NCT02959944 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT02959944?
The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG), ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02959944?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02959944 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Graft Versus Host Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02959944's enrollment target sits among peer trials
193 7th of 30 higher than 24 of 30 other Chronic Graft Versus Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Graft Versus Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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