Detail of the clinical trial

Title of the trial Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects - 75 Years of Age with Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia
EudraCT number 2017-001600-29
Protocol number ARO-013
Sponsor Arog Pharmaceuticals, Inc., 5420 LBJ Freeway, Suite 410, Dallas, TX 75240, United States of America
Indications Hematology
Diagnosis Refractory FLT3 Mutated Acute Myeloid Leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2018
Date of approval by Institute (SÚKL) 20.4.2018
Date of approval by EC
Date of initiation CT in ČR
Date of ending CT in ČR
Notice
Sites Fakultní nemocnice Olomouc, I. P., Pavlova 185/6,Olomouc,779 00
IV. Interni Hematologicka Klinika, Sokolská 581,Hradec, Králové - Nový Hradec Králové,500 05
FN Brno, Jihlavská 20,BRNO,CZ - 625 00
Fakultní nemocnice Královské Vinohrady, Šrobárova 1150/50,Praha 10,PSČ 100 34
Ústav hematologie a krevní transfuze (UHKT), U Nemocnice 2094/1,Praha 2,128 20

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