Trial Search Results

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With 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 currently not accepting patients for this trial.

Lead Sponsor:

Pharmacyclics LLC.

Intervention(s):

  • Drug: Ibrutinib

Phase:

Phase 1/Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting