Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
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
Karnofsky or Lansky (subjects <16 years of age) performance status ≥60
Key Eligibility:
Exclusion Criteria:
Westmead, New South Wales 2145, Australia
Moscow, 117997, Russia
Saint Petersburg, 197022, Russia