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
Graft Versus Host DiseasePCYC1129PCYC1129CA1129IbrutinibPCI32765IMBRUVICAPharmacyclicsPCYCGVHDSteroid dependentrefractorychronicchronic graft versus host diseaseimmunology
You can join if…
Open to people ages 18 years and up
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.
You CAN'T join if...
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.
University of California, San Francisco San Francisco, California, 94143, United States
Stanford University Stanford, California, 94305, United States
City of Hope Medical Center Duarte, California, 91010, United States