Detail of the clinical trial

Title of the trial A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil monotherapy in previously untreated patients with chronic lymphocytic leukemia
EudraCT number 2008-004932-19
Protocol number OMB110911
Sponsor GlaxoSmithKline Research Development, Harlow, UK
Indications Hemato-oncology
Diagnosis Chronic Lymphocytic Leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2008
Date of approval by Institute (SÚKL) 16.02.2009
Date of approval by EC 26.11.2008
Date of initiation CT in ČR 28.04.2009
Date of ending CT in ČR 26.6.2018 (25.1.2018)
Notice
Sites FN Královské Vinohrady, Odd. klinické hematologie, Praha 10
FN Hradec Králové, 2. interní klinika, Hradec Králové
FN Brno, Interní hematoonkologická klinika, Brno

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