Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease

Trial ID or NCT#

NCT02195869

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Sally Arai
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov