• GEOQ
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
Site Anatomique Pédiatrique divers
Phase Phase III
Stade
Type étude
Médicament Ibrutinib et predisone
Institution CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
Ville Montréal
Investigateur principal Dr Henrique Bittencourt
Coordonnateur Anthony Gallego
Statut Actif en recrutement
Date d'activation
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)