Trial Search Results

Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Subjects With New Onset cGVHD

Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or hematopoietic cell transplant from another person (allogeneic transplant). 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 new onset cGVHD can tolerate ibrutinib and whether their cGVHD responds to ibrutinib in combination with corticosteroids.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Pharmacyclics LLC.

Collaborator: Janssen Research & Development, LLC

Intervention(s):

  • Drug: ibrutinib
  • Drug: Placebo
  • Drug: Prednisone

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - New onset moderate or severe cGVHD as defined by the 2014 NIH Consensus Development
   Project Criteria

   - Need for systemic treatment with corticosteroids for cGVHD

   - No previous systemic treatment for cGVHD (including extracorporeal photopheresis
   [ECP])

   - Participants may be receiving other immunosuppressants for the prophylaxis or
   treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or
   treatment of acute GVHD it must be at or below 0.5 mg/kg/d

   - Age ≥12 years old

   - Karnofsky or Lansky (subjects <16 years) performance status ≥60

Exclusion Criteria:

   - Received any previous systemic treatment for cGVHD with the exception of
   corticosteroids administered for cGVHD within the 72 hours prior to signing the
   informed consent form.

   - Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD

   - Any uncontrolled infection or active infection requiring ongoing systemic treatment

   - Progressive underlying malignant disease or any post-transplant lymphoproliferative
   disease

   - Known bleeding disorders

   - Active hepatitis C virus (HCV) or hepatitis B virus (HBV)

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Janet McDowell
650-725-1647
Recruiting