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

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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.


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
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sites
1100 Fairview Avenue North
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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Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-625-1610
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Atlanta, Georgia 30322
Phone: 404-778-3708
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Atlanta, GA
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450 Brookline Ave
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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Boston, MA
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Columbus, Ohio 43210
Phone: 614-688-7562
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Columbus, OH
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Duarte, California 91010
Phone: 626-256-4673
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Nashville, Tennessee 37232
Phone: 615-875-6120
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San Francisco, California 94143
Phone: 415-476-4125
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St. Louis, Missouri 63108
Phone: 314-747-2449
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-721-2372
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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