Detail of the clinical trial
| Title of the trial | A Single-Arm, International, Multi-Center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients with B-Cell Chronic Lymphocytic Leukemia who Progressed Following Response or Stable Disease after Ofatumumab Treatment in Hx-CD20-406 |
|---|---|
| EudraCT number | 2008-001507-39 |
| Protocol number | GEN416 |
| Sponsor | GlaxoSmithKline, UNITED KINGDOM |
| Indications | Hemato-oncology |
| Diagnosis | B-cell 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) | 7.11.2008 |
| Date of approval by EC | 16.1.2009 |
| Date of initiation CT in ČR | 6.4.2009 |
| Date of ending CT in ČR | 7.7.2011 (4.6.2012) |
| Notice | |
| Sites |
Klinika hemato-onkologie, FNKV Praha 10 2.interní klinika - hematologická klinika, FN Hradec Králové Interní hemato-onkologická klinika, FN Brno - Bohunice 1. interní hemato-onkologická klinika, VFN Praha 2 |
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