Clinical Trial: Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD) (iNTE

Brief Summary: To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Detailed Summary:
Sponsor: Pharmacyclics LLC.

Current Primary Outcome: Response rate at 24 weeks [ Time Frame: up to 24 weeks ]

Response will be defined by the NIH Consensus Development Project Criteria (2014)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of subjects with steroid dose reduction at 24 weeks [ Time Frame: 24 weeks ]
  • Withdrawal of all immunosuppressants at 48 weeks [ Time Frame: 48 weeks ]
  • Overall survival (OS) from time of randomization until the time of death due to any cause [ Time Frame: Approximately 3 years after the first subject is randomized ]
  • Response rate at 48 weeks [ Time Frame: up to 48 weeks ]
  • Number of participants with adverse events as a measure of safety and tolerability of ibrutinib and prednisone versus placebo in combination with prednisone [ Time Frame: Up to 30 days after the last participating subject discontinues study drug ]


Original Secondary Outcome: Same as current

Information By: Pharmacyclics LLC.

Dates:
Date Received: October 25, 2016
Date Started: December 2016
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017