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) Male Female Patients |
| 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) |
| Notice | |
| 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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