273
Participants
Start Date
September 5, 2019
Primary Completion Date
October 3, 2024
Study Completion Date
January 24, 2025
Quizartinib
"Induction: oral quizartinib (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.~Consolidation: oral quizartinib (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.~Maintenance: oral quizartinib 60mg/day (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days."
Placebo oral tablet
"Induction: oral placebo (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.~Consolidation: oral placebo (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.~Maintenance: oral placebo 60mg/day (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days."
Cytarabine
"Induction: Cytarabine continuous IV infusion, 200 mg/m2 (days 1-7), up to 2 cycles of 35 days.~Consolidation: Cytarabine IV infusion, 1,5-3 g/m2 (days 1, 3, 5), up to 4 cycles of 35 days."
Idarubicin
Induction: Idarubicin IV infusion 12 mg/m2 (days 1-3), up to 2 cycles of 35 days.
Hospital San Pedro de Alcántara, Cáceres
Hospital General Univesitario de Castellón, Castellon
Complejo Hospitalario Regional Reina Sofía, Córdoba
Complejo Hospitalario Universitario de A Coruña, Santiago de Compostela
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela
Hospital Juan Ramón Jiménez, Huelva
Complejo Hospitalario de Jaén, Jaén
Complejo Hospitalario Lucus Augusti, Lugo
Fundación Jiménez Díaz, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario Quirón Salud Madrid, Pozuelo de Alarcón
Hospital Regional Universitario Málaga, Málaga
Hospital Universitario Virgen de la Victoria, Málaga
Hospital General Universitario Santa Lucía, Cartagena
Complejo Universitario de Navarra, Pamplona
Hospital Universitario Central de Asturias, Oviedo
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria
Complejo Hospitalario de Pontevedra, Pontevedra
Complejo Hospitalario Universitario de Vigo, Vigo
Hospital Universitario de Salamanca, Salamanca
Hospital Universitario de Canarias, San Cristóbal de La Laguna
Hospital Universitario Marques de Valdecilla, Santander
Complejo Hospitalario Regional Virgen del Rocío, Seville
Complejo Hospitalario de Toledo, Toledo
Hospital Clínico Universitario Valencia, Valencia
Hospital Universitario Dr. Peset Aleixandre, Valencia
Hospital Universitari i Politecnic La Fe, Valencia
Hospital Clínico Universitario de Valladolid, Valladolid
Hospital Universitario de Basurto, Bilbao
Hospital Universitario de Galdakao, Galdakao
Hospital Clínico Universitario Lozano Blesa, Zaragoza
Hospital Universitario Miguel Servet, Zaragoza
Hospital Universitari Germans Trias i Pujol, Badalona
Complejo Hospitalario de Albacete, Albacete
Hospital General Universitario de Alicante, Alicante
Hospital Universitari Vall Hebron, Barcelona
Hospital Universitario de Burgos, Burgos
Hospital Puerta del Mar, Cadiz
Hospital Clínico San Carlos, Madrid
Hospital La Paz, Madrid
Hospital Ramón y Cajal, Madrid
Hospital Virgen de la Arrixaca, Murcia
Hospital Nuestra Señora del Prado, Talavera de la Reina
Hospital Txagorritxu, Vitoria-Gasteiz
Collaborators (1)
Dynamic Science S.L.
INDUSTRY
Daiichi Sankyo
INDUSTRY
PETHEMA Foundation
OTHER