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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