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PCYC-1146 : Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Male or<br/>FemaleGender Male or

Closed (no longer recruiting)Status Closed (no longer recruiting)

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

1-21Age 1-21

Blood<br/>CancersCancer LocationBlood

Systemic therapy,Treatment | Blood / Myeloma / LymphomaGraft versus Host disease

Trial Overview Read MoreRead more

This phase I/II trial is evaluating a targeted therapy to treat children and adolescents diagnosed with chronic graft versus host disease.

This trial is treating patients with chronic Graft Versus Host Disease (cGVHD).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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.


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="" 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="">

Not Recruiting Hospitals Read MoreRead more


Royal Childrens Hospital
Trial Coordinator

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.