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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)
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)
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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