Detail of the clinical trial

Title of the trial An open-label, multi?center, Phase IIIb study to assess the safety and efficacy of midostaurin (PKC412) in patients 18 years of age or older with newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML) who are eligible for ?7+3? or ?5+2? chemotherapy
EudraCT number 2016-004440-12
Protocol number CPKC412A2408
Sponsor Novartis Pharma AG, Lichtstrasse 35, Basel 4056, Switzerland
Indications Hemato-oncology
Diagnosis acute myeloid leukemia (AML)
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2017
Date of approval by Institute (SÚKL) 5.1.2018
Date of approval by EC 25.10.2017
Date of initiation CT in ČR 30.3.2018
Date of ending CT in ČR 18.8.2020
Sites Fakultni nemocnice Brno,Interni hematologicka a onkologicka klinika,Jihlavska 20,,625 00
Fakultni nemocnice Kralovske Vinohrady,Interni hematologicka klinika,Srobarova 1150/50,Praha,100 34

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