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Detail of the clinical trial

Title of the trial Phase III open-label randomized study of amonafide L-maleate in combination with cytarabine compared to daunorubicin in combination with cytarabine in patients with secondary acute myeloid leukemia (AML)
EudraCT number 2007-004427-38
Protocol number 0001A3-300-GL
Sponsor Antisoma Research Ltd., Londýn, UK
Indications Hemato-oncology
Diagnosis secondary acute myeloid leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2008
Date of approval by Institute (SÚKL) 2.1.2009
Date of approval by EC 5.2.2009
Date of initiation CT in ČR 13.10.2009
Date of ending CT in ČR 31.1.2011
Sites Odd. klinické hematologie, FNKV Praha 10
1. interní klinika VFN Praha 2
Institut hematologie a krevní transfuze, Praha 2

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