Detail of the clinical trial
| Title of the trial | A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator´s choice of anti-leukemic treamtent in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1) |
|---|---|
| EudraCT number | 2010-023499-25 |
| Protocol number | 1230.25 |
| Sponsor | Boehringer Ingelheim RCV GmbH & Co. KG, Rakousko |
| Indications | Hemato-oncology |
| Diagnosis | leukemia |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2011 |
| Date of approval by Institute (SÚKL) | 26.7.2011 |
| Date of approval by EC | 27.6.2011 |
| Date of initiation CT in ČR | |
| Date of ending CT in ČR | |
| Notice | |
| Sites |
FN Hradec Králové, 2. interní klinika - odd. klnické hematologie Ústav hematologie a krevní transfuze, Praha 2 1. LF UK a VFN, I. interní klinika, Praha FNKV, Odd. klinické hematologie, Praha 10 |
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