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

• Status: Completed
• Trial end date: 2017-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.

Criteria

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.