Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Key Eligibility:

Inclusion criteria

• Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy
• Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of systemic immunosuppression
• History of allogeneic stem cell transplantation
• Age

• Part A: ≥1 to <12 years of age at the time of enrollment
• Part B: ≥1 to <22 years of age at the time of enrollment
• Karnofsky or Lansky (subjects <16 years of age) performance status ≥60

Key Eligibility:

Exclusion criteria

• Presence of single organ genito-urinary involvement as the only manifestation of cGVHD
• Received an investigational agent within 28 days before enrollment.
• Received donor lymphocyte infusion (DLI) within 56 days before enrollment
• Progressive underlying malignant disease or active post-transplant lymphoproliferative disease
• Any uncontrolled infection or active infection requiring ongoing systemic treatment
• Known bleeding disorders
• Active hepatitis C virus (HCV) or hepatitis B virus (HBV)