Status:
COMPLETED
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02195869
Start Date
July 14 2014
End Date
September 15 2017
Last Update
July 11 2019
Active Locations (10)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322