Detail of the clinical trial

Title of the trial An open-labeled, randomized, two-dose, paralel group trial of ofatumumab, a fully human monoclonal anti-CD20 antibody, in combination with fludarabine and cyclophosphamide, in patiens with previously untreated B-cellchronic Lymphocytic leukemia
EudraCT number 2007-000243-10
Protocol number Hx-CD20-407
Sponsor Genmab A/S, Dansko
Indications Hemato-oncology
Diagnosis CLL
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2007
Date of approval by Institute (SÚKL) 24.01.2008
Date of approval by EC 17.01.2008
Date of initiation CT in ČR 27.03.2008 0:00:00
Date of ending CT in ČR 14.8.2013
Notice
Sites Interní hematoonkologická klinika, FN Brno-Bohunice, Jihlavská 20, Brno
II. interní klinka, oddělení klinické hematologie, FN Hradec Králové, Sokolská 581, Hradec Králové
Interní hematoonkologická klinika, VFN v Praze, U Nemocnice 2, Praha
Oddělení klinické hematologie, FN Královské Vinohrady, Šrobárova 50, Praha

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