Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Orthopedic, Hematology |
Therapuetic Areas: | Hematology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | July 2014 |
A Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Steroid Dependent or Refractory Chronic Graft Versus Host Disease
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.
subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.
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.
We found this trial at
10
sites
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Phone: 206-667-6819
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6715
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Nashville, Tennessee 37232
Phone: 615-875-6120
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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