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.
Andrew Rezvani, M.D.

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
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

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