Detail of the clinical trial

Title of the trial Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia.
EudraCT number 2007-007587-21
Protocol number 994
Sponsor GCLLSG-Dept.of Internal Medicine I, University Hospital Cologne, GERMANY
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) 2010
Date of approval by Institute (SÚKL) 14.10.2010
Date of approval by EC 1.10.2010
Date of initiation CT in ČR 28.3.2011
Date of ending CT in ČR 15.2.2018
Notice
Sites FN Hradec Králové, hematoonk.kl. (discontinued)
VFN, I.interní klinika-hematologie
FN Olomouc, hemato-onk.klinika
FN Královské Vinohrady, odd.kl.hematologie (discontinued)
FN Brno, Interní hemato-onk.kl. (discontinued)

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