2
Participants
Start Date
December 31, 2019
Primary Completion Date
February 17, 2020
Study Completion Date
February 17, 2020
Itacitinib
Phase 1: Itacitinib administered orally once daily at the protocol-defined dose according to age cohort, with dose reductions or modifications based on safety assessments. Phase 2: Itacitinib administered orally once daily at the recommended dose from Phase 1.
Corticosteroids
Phase 1 and 2: Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of disease as outlined per local treatment guidelines as background treatment.
Memorial Sloan Kettering Cancer Center, New York
AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita, Torino
Hospital Clinico de Santiago de Compostela, Santiago de Compostela
Children's Hospital of Philadelphia - Center for Childhood Cancer Research, Philadelphia
Nemours/A.I. duPont Hospital for Children, Wilmington
Fondazione MBBM, Monza
Duke University Medical Center, Durham
Nicklaus Children's Hospital, Miami
Centre Hospitalier Universitaire de Rennes, Rennes
Sarah Cannon Research Institute, LLC, Nashville
CHU de Grenoble, Grenoble
CHU de Grenoble, Grenoble
Policlinico S. Orsola-Malpighi, Bologna
University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital, Cleveland
Hospital Universitari i Politecnic La Fe, Valencia
Universitaetsklinikum Aachen, AoeR, Aachen
CHRU Nancy, Vandœuvre-lès-Nancy
CHU Nancy, Vandœuvre-lès-Nancy
University of Minnesota Medical Center, Minneapolis
Hopitaux Universitaires De Strasbourg, Strasbourg
Hopitaux Universitaires De Strasbourg, Strasbourg
Robert Debre Hospital, Paris
Children's Hospital Colorado - Center for Cancer and Blood Disorders, Aurora
City of Hope National Medical Center, Duarte
Childrens Hospital of Orange County, Orange
Azienda Ospedaliero Unversitatia Policlinico - Vittorio Emanuele - Presido Ospedaliero G. Rodolico, Catania
Doernbecher Children's Hospital - Division of Pediatric Hematology, Portland
Vanderbilt University Medical Center, Nashville
Fred Hutchinson Cancer Research Center, Seattle
Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin, Jena
Ospedale Pediatrico Bambino Gesu, Roma
Hospital Vall D Hebron, Barcelona
Birmingham Childrens Hospital, Birmingham
Bristol Royal Hospital for Children, Bristol
Leeds Teaching Hospitals NHS Trust, Leeds
Great Ormond Street Hospital for Children, London
Central Manchester University Hospital - Royal Manchester Children's Hospital, Manchester
Royal Marsden Hospital - Surrey, Surrey Quays
Lead Sponsor
Incyte Corporation
INDUSTRY