Ibrutinib and Rituximab for Steroid-Refractory or Dependent Chronic GVHD

Inclusion Criteria

• Recipients of an allogeneic bone marrow, cord blood or peripheral blood stem cell transplant. * (There will be no restrictions based upon underlying disease, donor source, degree of human leukocyte match [HLA] match, intensity of pre-transplant conditioning regimen or use of prior donor lymphocyte infusion[s].)
• Chronic GVHD that is confirmed by clinical assessment and/or biopsy.
• Either steroid-refractory or steroid-dependent chronic (c)GVHD.
• Karnofsky performance status >= 60.

Exclusion Criteria

• History of treatment with a tyrosine kinase inhibitor (eg, imatinib) or other moderate-to-significant CYPA4 inhibitor within 2 weeks of enrollment.
• Renal insufficiency as follows: creatinine > 2.5 mg/dL or creatinine clearance (CrCl) < 30 ml/min.
• Hepatic insufficiency as follows: serum bilirubin > 3 mg/dL or grade 3 or greater transaminitis at baseline (even if deemed due to GVHD) or cirrhosis (any Childs Pugh class).
• History of cardiac dysrhythmias or known cardiovascular disease without formal cardiology clearance.
• History of cerebro-vascular accident or intracranial hemorrhage within 6 months prior to enrollment.
• History of non-intracranial hemorrhage and/or coagulopathy without formal coagulation clearance.
• Uncontrolled infections not responsive to antibiotics, anti-viral medicines, or anti-fungal medicines; or infection requiring systemic treatment that was completed =< 14 days before enrollment.
• History of other hematologic malignancy.
• History of human immunodeficiency virus (HIV).
• History of active hepatitis B virus (HBV) or hepatitis C virus (HCV) without formal infectious disease clearance.
• Patients incapable of complying with routine follow up schedule or unable to be compliant with study therapy.
• Active or within 3 months use of prohibited medications or substances (e.g., illicit drugs).