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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

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

Trial ID or NCT#

NCT02195869

Status

NOT 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:

- 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.

View All Criteria

Investigator(s)

Sally Arai

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist

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

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)

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)

CONTACT

CCTO
(650) 498-7061

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To:

New to MyHealth?

ALREADY HAVE AN ACCESS CODE?

DON'T HAVE AN ACCESS CODE?

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: