Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
Trial ID or NCT#
The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.
A Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Steroid Dependent or Refractory Chronic Graft Versus Host Disease
- - Steroid dependent or refractory classic chronic GVHD disease. - No more than 3 previous treatments for cGVHD. - Receiving baseline systemic glucocorticoid therapy (at stable dose) for cGVHD at study entry. - Men and women ≥18 years old. - Karnofsky performance status ≥60.
- - Known or suspected active acute GVHD. - Current treatment with sirolimus AND either cyclosporine or tacrolimus. - History of treatment with a tyrosine kinase inhibitor (eg, imatinib), purine analogs or other cancer chemotherapy in the 4 weeks prior to starting study drug. - Currently active, clinically significant cardiovascular disease. - Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ≤14 days before the first dose of study drug. - Progressive underlying malignant disease including post-transplant lymphoproliferative disease. - History of other malignancy (not including the underlying malignancy that was the indication for transplant) - Concomitant use of warfarin or other Vitamin K antagonists - Known bleeding disorders or hemophilia. - History of stroke or intracranial hemorrhage within 6 months prior to enrollment. - Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). - Concurrent use of a strong cytochrome P450(CYP) 3A inhibitor.
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