Clinical Trials Directory

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

Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or hematopoietic cell transplant from another person (allogeneic transplant). It is steroid refractory when the standard medications (steroids) do not control or improve its manifestations and is steroid dependent when you are unable to taper steroids off without the return of GVHD. Other than steroids, no other therapy has been shown in randomized controlled trials to be effective in cGVHD. Chronic GVHD is the major problem of allogeneic transplantation and new therapies are desparately needed. This study will determine if subjects with steroid dependent or refractory cGVHD can tolerate ibrutinib and whether their cGVHD responds to ibrutinib.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Ibrutinib

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

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.

External Links

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Janet McDowell
650-725-1647
Not Recruiting

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