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
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

1-21Age 1-21

Blood<br/>CancersCancer LocationBlood
Cancers

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.

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="" 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="" dose.="">

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

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.

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