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Detail of the clinical trial

Title of the trial An open label, multicenter study investigating the safety and efficacy of ofatumumab therapy versus physicians´choice in patients with bulky fludarabine refractory chronic lymphocytic leukaemia (CLL)
EudraCT number 2010-023066-52
Protocol number OMB114242
Sponsor GlaxoSmithKline Research and Development Ltd, Uxbridge, United Kingdom
Indications Hemato-oncology
Diagnosis chronic lymphocytic 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) 25.3.2011
Date of approval by EC 17.3.2011
Date of initiation CT in ČR
Date of ending CT in ČR 2.5.2013
Sites 2. interní klinika - odd. klinické hematologie, FN Hradec Králové
1. interní klinika - VFN Praha 2
Hematoonkologická klinika, FN Olomouc

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