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

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)