Detail of the clinical trial
| Title of the trial | A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil monotherapy in previously untreated patients with chronic lymphocytic leukemia |
|---|---|
| EudraCT number | 2008-004932-19 |
| Protocol number | OMB110911 |
| Sponsor | GlaxoSmithKline Research Development, Harlow, UK |
| 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) | 2008 |
| Date of approval by Institute (SÚKL) | 16.02.2009 |
| Date of approval by EC | 26.11.2008 |
| Date of initiation CT in ČR | 28.04.2009 |
| Date of ending CT in ČR | 26.6.2018 (25.1.2018) |
| Notice | |
| Sites |
FN Královské Vinohrady, Odd. klinické hematologie, Praha 10 FN Hradec Králové, 2. interní klinika, Hradec Králové FN Brno, Interní hematoonkologická klinika, Brno |
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