Detail of the clinical trial

Title of the trial A phase III, randomized, double-blind study of chemotherapy with daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation plus midostaurin (PKC412) or chemotherapy plus placebo in newly diagnosed patients with FLT-3 mutation negative acute myeloid leukemia (AML)
EudraCT number 2017-003540-21
Protocol number CPKC412E2301
Sponsor Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland
Indications Hemato-oncology
Diagnosis Myeloid leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2018
Date of approval by Institute (SÚKL) 4.5.2018
Date of approval by EC
Date of initiation CT in ČR 10.9.2018
Date of ending CT in ČR 26.2.2021
Sites FN Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno,625 00
Fakultní nemocnice Plzeň,Hematoonkologicko-Onkologické oddělení,Alej Svobody 80,Plzeň,304 60

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