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Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
Not Recruiting
Trial ID: NCT02195869
Purpose
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.
Official Title
A Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Steroid Dependent or Refractory Chronic Graft Versus Host Disease
Stanford Investigator(s)
Andrew Rezvani, M.D.
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Intervention(s):
drug: Ibrutinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061