Trial Identifiers
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Scientific Title
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
Commercial Sponsor
Pharmacyclics LLC. & Janssen Research & Development, LLC.
Summary
This trial has two parts. In Part A, patients that are 1 to <12 years="" of="" age="" and="" have="" moderate="" or="" severe="" chronic="" graft="" versus="" host="" disease="" (cgvhd),="" will="" receive="" oral="" ibrutinib="" once="" daily="" to="" determine="" the="" recommended="" pediatric="" equivalent="" dose="" (rped).="" patients="" in="" part="" a="" of="" the="" trial="" may="" continue="" receiving="" daily="" ibrutinib="" until="" the="" rped="" is="" determined,="" at="" which="" time="" their="" dose="" may="" be="" adjusted="" to="" the="" rped.="" patients="">12>< 12="" years="" of="" age="" and="" enrolled="" in="" part="" b="" will="" receive="" ibrutinib="" at="" the="" rped="" dose.="" patients="" aged="" 12="" and="" over="" will="" receive="" oral="" ibrutinib="" once="" daily="" at="" a="" 420mg="">