Spots Global Cancer Trial Database for Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
Official Title: A 2:1 Randomized Phase II Trial to Compare the Efficacy and Safety of Standard Chemotherapy Plus Quizartinib Versus Standard Chemotherapy Plus Placebo in Adult Patients With Newly Diagnosed FLT3 Wild-type AML
Study ID: NCT04107727
Conditions
Study Description
Brief Summary: Randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type Acute Myeloid Leukemia
Detailed Description: Multicenter, prospective, randomized, placebo-controlled, double-blinded phase II trial to assess the efficacy and safety of an oral quizartinib vs. placebo containing front-line chemotherapy-based schedule in FMS-like tyrosine kinase 3 internal tandem duplications (FLT3-ITD) wild-type Acute Myeloid Leukemia patients. The trial will be conducted in two phases: An open-label safety run-in phase: Cytarabine 200 mg/m2 (days 1-7), Idarubicin 12 mg/m2 (days 1-3) Quizartinib 60 mg/d x 14 days (30mg with strong Cytochrome P450 Family 3 Subfamily A (CYP3A) inhibitor) in a total of 9 patients, being observed during 1 cycle of induction to define the final dose for the randomized phase. A randomized double-blinded phase 2:1 quizartinib (at the established dose) vs. placebo. Experimental Arm: Cytarabine 200 mg/m2 (days 1-7), Idarubicin 12 mg/m2 (days 1-3) Quizartinib 60 mg/d x 14 days (30mg with strong CYP3A inhibitor) Standard Arm: Cytarabine 200 mg/m2 (days 1-7), Idarubicin 12 mg/m2 (days 1-3) Placebo 60 mg/d x 14 days (30mg with strong CYP3A inhibitor) 272 patients will be included in this phase.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Complejo Hospitalario Universitario de A Coruña, Santiago De Compostela, A Coruña, Spain
Complejo Hospitalario Universitario de Santiago, Santiago De Compostela, A Coruña, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital General Univesitario de Castellón, Castellón De La Plana, Castellón, Spain
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín, Las Palmas De Gran Canaria, Las Palmas, Spain
Hospital Universitario Quirón Salud Madrid, Pozuelo De Alarcón, Madrid, Spain
Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain
Complejo Hospitalario Universitario de Vigo, Vigo, Pontevedra, Spain
Hospital Universitario de Canarias, La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario de Basurto, Bilbao, Vizcaya, Spain
Hospital Universitario de Galdakao, Galdakao, Vizcaya, Spain
Complejo Hospitalario de Albacete, Albacete, , Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Complejo Hospitalario Torrecárdenas, Almería, , Spain
Hospital Universitari Vall Hebron, Barcelona, , Spain
Hospital Universitario de Burgos, Burgos, , Spain
Hospital Puerta del Mar, Cadiz, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Complejo Hospitalario Regional Reina Sofía, Córdoba, , Spain
Hospital Juan Ramón Jiménez, Huelva, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Complejo Hospitalario Lucus Augusti, Lugo, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Virgen de la Arrixaca, Murcia, , Spain
Hospital Regional Universitario Málaga, Málaga, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Complejo Universitario de Navarra, Pamplona, , Spain
Complejo Hospitalario de Pontevedra, Pontevedra, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Complejo Hospitalario Regional Virgen del Rocío, Sevilla, , Spain
Hospital Nuestra Señora del Prado, Talavera De La Reina, , Spain
Complejo Hospitalario de Toledo, Toledo, , Spain
Hospital Clínico Universitario Valencia, Valencia, , Spain
Hospital Universitario Dr. Peset Aleixandre, Valencia, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valladolid, Valladolid, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Hospital Txagorritxu, Vitoria, Álava, Spain
Contact Details
Name: Pau Montesinos
Affiliation: Hospital Universitari i Politecnic La Fe
Role: PRINCIPAL_INVESTIGATOR
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