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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)
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
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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