Detail of the clinical trial
| Title of the trial | A randomized, open-label, multicenter, phase II/III study to evaluate the safety and efficacy of Lumiliximab in combination with Fludarabine, Cyclophosphamide and Rituximab versus Fludarabine, Cyclophosphamide and Rituximab alone in subjects with relapsed chronic lymphocytic leukemia. |
|---|---|
| EudraCT number | 2006-002987-24 |
| Protocol number | 152CL201 |
| Sponsor | Biogen Idec., Ltd., Velká Británie |
| Indications | Hemato-oncology |
| Diagnosis | relapsed 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) | 31.07.2008 |
| Date of approval by EC | 21.08.2008 |
| Date of initiation CT in ČR | 22.10.2008 |
| Date of ending CT in ČR | 22.02.2010 |
| Notice | |
| Sites |
Interní hematoonkologická klinika, FN Brno - Bohunice Odd.klinické hematologie FN KV, Praha 10 (discontinued) II. Interní klinika - odd.klinické hematologie, FN Hradec Králové I. Interní klinika VFN, Praha 2 |
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