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Summary

Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

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.

Official Title

A Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Steroid Dependent or Refractory Chronic Graft Versus Host Disease

Keywords

Graft Versus Host Disease PCYC1129 PCYC1129CA 1129 Ibrutinib PCI32765 IMBRUVICA Pharmacyclics PCYC GVHD Steroid dependent refractory chronic chronic graft versus host disease immunology

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Stanford University
    Stanford, California, 94305, United States
  • City of Hope Medical Center
    Duarte, California, 91010, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Pharmacyclics LLC.
ID
NCT02195869
Phase
Phase 1/2
Lead Scientist
Aaron Logan
Study Type
Interventional
Last Updated
April 2016