65
Participants
Start Date
August 15, 2018
Primary Completion Date
May 1, 2027
Study Completion Date
May 1, 2027
Quizartinib
"Administered orally once daily starting on Day 6 and continuing through Day 28;~Optional low intensity consolidation with chemotherapy:~Administered orally once daily starting on Day 1 and continuing through Day 28"
Fludarabine
30 mg/m\^2/day IV infusion given over 30 minutes on Days 1 through 5 (administered based on body weight)
Cytarabine
"2000 mg/m\^2/day IV infusion given over 3 hours on Days 1 through 5 (begin 4 hours after the start of fludarabine) (administered in accordance with standard of care);~Optional high intensity consolidation with chemotherapy and quizartinib:~500 mg/m\^2/day as a continuous 96-hour IV infusion on Days 1 through 4;~Optional low intensity consolidation with chemotherapy:~75 mg/m\^2/day as once daily subcutaneous or IV on Days 1 through 4 and Days 15 through 18"
Intrathecal (IT) triple chemotherapy prophylaxis
IT cytarabine, methotrexate, and either prednisolone or hydrocortisone; doses are based on the participant's age and standard practice at each site
Etoposide
"Optional high intensity consolidation with chemotherapy and quizartinib:~100 mg/m\^2/dose once daily as an IV infusion over 3 hours on Days 1 through 5"
Rigshospitalet, Copenhagen
Ospedale Infantile Regina Margherita, Torino
UPMC Children's Hospital of Pittsburgh, Pittsburgh
A.I. duPont Hospital for Children, Wilmington
Children's National Medical Center, Washington D.C.
Fondazione IRCCS San Gerardo dei Tintori, Monza
Hospital Infantil Universitario Nino Jesus, Madrid
Hospital Universitario La Paz, Madrid
Children's Healthcare of Atlanta, Atlanta
Rambam Medical Center, Haifa
Hôpital des Enfants, Toulouse
Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus, Gothenburg
Cincinnati Children's Hospital Medical Center, Cincinnati
University of Minnesota/Masonic Cancer Center, Minneapolis
Tel Aviv Sourasky Medical Center, Tel Aviv
Centre Léon Bérard, Lyon
Hôpital Armand-Trousseau, Paris
The University of Texas Southwestern Medical Center Children's Health, Dallas
Children's Hospital Colorado, Aurora
Loma Linda University Cancer Center, Loma Linda
University of California, San Francisco, San Francisco
Seattle Children's Hospital, Seattle
Universitair Ziekenhuis Gent, Ghent
The Hospital for Sick Children, Toronto
British Columbia Children's Hospital, Vancouver
IRCCS Ospedale Pediatrico Bambino Gesù, Rome
Prinses Maxima Centrum voor Kinderoncologie, Utrecht
Lead Sponsor
Innovative Therapies For Children with Cancer Consortium
OTHER
Children's Oncology Group
NETWORK
Daiichi Sankyo
INDUSTRY