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
Type étude
Médicament Ibrutinib et predisone
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)