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Detail of the clinical trial

Title of the trial A phase III, multi-center, open-label, randomised study of the efficacy of nilotinib versus imatinib in adult patients with Philadelphia chromosome positive Ph+ chronic myelogenous leukemia in chronic phase (CML-CP) who have suboptimal cytogenetic response (CyR) on imatinib
EudraCT number 2005-005047-26
Protocol number CAMN107A2302
Sponsor Novartis Pharma Services, Basilej, Švýcarsko
Indications Hemato-oncology
Diagnosis Myelogenous leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2007
Date of approval by Institute (SÚKL) 27.08.2007
Date of approval by EC
Date of initiation CT in ČR
Date of ending CT in ČR 29.05.2008
Sites Interní hematoonkologická klinika, FN Brno-Bohunice, Jihlavská 20
Hematoonkologické oddělení, FN Olomouc, I. P. Pavlova 6
Ústav hematologie a krevní transfuze, UHKT, U Nemocnice 1, Praha 2

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