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, USA
Stanford University Stanford, California, 94305, USA
City of Hope Medical Center Duarte, California, 91010, USA