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

Prior treatment

• Received an investigational agent within 28 days before enrollment.

Other illness

• 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)

Lab values

• Received donor lymphocyte infusion (DLI) within 56 days before enrollment

Other

• Presence of single organ genito-urinary involvement as the only manifestation of cGVHD

• 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:

Criteria the registry did not label

• Key Eligibility: