Detail of the clinical trial

Title of the trial A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ?18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy
EudraCT number 2016-004724-34
Protocol number PRAN-16-52
Sponsor Helsinn Healthcare SA, Via Pian Scairolo 9, Lugano - 6912, Switzerland
Indications Hemato-oncology
Diagnosis 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) 2017
Date of approval by Institute (SÚKL) 8.1.2018
Date of approval by EC 10.5.2017
Date of initiation CT in ČR 10.4.2018
Date of ending CT in ČR 10.7.2020
Notice IDMC recommended to stop the study prematurely due to a lack of efficacy.
Sites Fakultní nemocnice Královské Vinohrady,Interní hematologická klinika,Šrobárova 1150/50 ,Praha 10,10034
Fakultní nemocnice Olomouc ,Hemato-onkologická klinika ,I. P. Pavlova 185/6 ,OLOMOUC,779 00
Všeobecná fakultní nemocnice v Praze,I.interní klinika - klinika hematologie,U Nemocnice 499/2 ,Praha 2,12808
Fakultní nemocnice Hradec Králové,IV. interní hematologická klinika,Sokolská 581,Hradec Králové,50005

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