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Detail of the clinical trial

Title of the trial A phase III randomized open-label study evaluating the efficacy and safety of idelalisib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab for previously untreated chronic lymphocytic leukemia.
EudraCT number 2013-004551-20
Protocol number GS-US-312-0118
Sponsor Gilead Sciences, Inc., 333 Lakeside Drive, 94404 Foster City, CA, United States of America
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) 2015
Date of approval by Institute (SÚKL) 15.6.2015
Date of approval by EC
Date of initiation CT in ČR
Date of ending CT in ČR 11.3.2016 (7.3.2016)
Sites Fakultní nemocnice Brno, Interní hematoonkoligkcá klinika, Jihlavská 20, 625 00 Brno
Fakultní nemocnice Hradec Králové, IV. interní hematologická klinika, Sokolská 581, 500 05 Hradec Králové
Fakultní nemocnice Královské Vinohrady, Interní hematologická klinika, Šrobárova 50, 100 34 Praha 10
Fakultní nemocnice Ostrava, Klinika hematoonkologie, 17. listopadu 1790, 708 52 Ostrava

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