Groupe d'Etude en Oncologie du Quebec

Titre	Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)
Protocole ID	PCYC-1140-IM
ClinicalTrials.gov ID	NCT02959944
Type(s) de cancer	Pédiatrique divers
Phase	Phase III
Médicament	Ibrutinib et predisone
Institution	CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
Ville	Montréal
Investigateur(trice) principal(e)	Dr Henrique Bittencourt
Coordonnateur(trice)	Anthony Gallego 514-345-4931 poste 3627
Statut	Fermé
Critètes d'éligibilité	12 Years and older New onset moderate or severe cGVHD as defined by the 2014 NIH Consensus Development Project Criteria Need for systemic treatment with corticosteroids for cGVHD No previous systemic treatment for cGVHD (including extracorporeal photopheresis [ECP]) May be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but the doses of these medications must have been stable for at least 2 weeks prior to Screening Age ≥12 years old Karnofsky or Lansky (subjects <16 years) performance status ≥60
Critètes d'exclusion	Received any previous systemic treatment for cGVHD Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD Any uncontrolled infection or active infection requiring ongoing systemic treatment Progressive underlying malignant disease or any post-transplant lymphoproliferative disease Known bleeding disorders Active hepatitis C virus (HCV) or hepatitis B virus (HBV)

Groupe d'étude en oncologie du Québec