Detail of the clinical trial

Title of the trial A phase III randomized, double-blind study of induction (daunorubicin/cytarabine) and consolidation (high-dose cytarabine) chemotherapy + midostaurin (PKC 412) (IND # 10161) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML).
EudraCT number 2006-006852-37
Protocol number CPKC412A2301 CALGB10603/CTSUC10603
Sponsor Novartis Pharma AG, Basel, SWITZERLAND
Indications Hemato-oncology
Diagnosis Acute Myeloid Leukemia With FL3 Mutation
Population in clinical trial Adults (18-65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2008
Date of approval by Institute (SÚKL) 03.10.2008
Date of approval by EC 13.10.2008
Date of initiation CT in ČR 27.03.2009
Date of ending CT in ČR
Notice
Sites Odd. klinické hematologie, FN KV Praha 10
Hemato-onkologická klinika, FN Olomouc (discontinued)
II. Interní klinika, odd.klinické hematologie, FN Hradec Králové (discontinued)
Ústav hematoonkologie a krevní transfuze, klinický úsek, U nemocnice 1, Praha 2
Interní hematoonkologická klinika, FN Brno Bohunice

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