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.
- drug : Ibrutinib
Phase: Phase 1/Phase 2
Ages Eligible For Study:
- 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.