A Randomized, Double-Blind Phase 3 Study of Ibrutinib inCombination With Corticosteroids versus Placebo in Combination With Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD)

Protocol: 
AAAR1134
Phase: 
III

A Randomized, Double-Blind Phase 3 Study of Ibrutinib inCombination With Corticosteroids versus Placebo in Combination With Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD)

This is a research study of a new drug for the treatment of new onset chronic graft versus host disease (cGVHD). Chronic GVHD is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted donor cells attack the transplant recipient's body. The current way to treat cGVHD is to use prednisone (a type of corticosteroid), but its use is limited because of its side effects. This study is being done to determine if a new drug (Ibrutinib) can help shorten the time that prednisone is needed and reduce the symptoms of cGVHD better than prednisone alone. Pharmacyclics LLC (Sponsor) is studying the effects of combining two drugs: ibrutinib and prednisone compared to placebo (sometimes called a “sugar pill”) and prednisone in subjects with chronic Graft Versus Host Disease (cGVHD).

Are you Eligible? (Inclusion Criteria)

1. New onset moderate or severe cGVHD as defined by the NIH Consensus
Development
Project Criteria.
2. History of an allogeneic hematopoietic cell transplant.
3. Need for systemic treatment with corticosteroids for cGVHD.
4. No previous systemic treatment for cGVHD (including extracorporeal
photopheresis [ECP]).

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States