Detail of the clinical trial

Title of the trial A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ? 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy.
EudraCT number 2012-002487-27
Protocol number 1230.14
Sponsor Boehringer Ingelheim RCV GmbH & Co KG,Dr. Boehringer-Gasse 5-11,Vienna,A-1121
Indications Hemato-oncology
Diagnosis myeloid leukaemia
Population in clinical trial Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2012
Date of approval by Institute (SÚKL) 7.2.2013
Date of approval by EC 13.3.2012
Date of initiation CT in ČR 11.6.2013
Date of ending CT in ČR
Notice
Sites Fakultni nemocnice Plzen,Hematologicko-onkologicke oddeleni,Alej Svobody 80,Plzen Lochotin,604 60
FN Kralovske Vinohrady,Interni hematologicka klinika,Srobarova 50,Praha 10,100 34
Fakultni nemocnice Brno,Interni hematologicka a onkologicka klinika,Jihlavska 20,Brno,625 00 (discontinued)
FN Hradec Králové, IV.Interní hematologická klinika, Sokolská 581, Hradec Králové, 500 05

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