Detail of the clinical trial

Title of the trial Randomized, double-blind, placebo-controlled phase 3 stuy of Ibrutinib,a Bruton´s Tyrosine Kinase (BTK) inhibitor, in combination with Bendamustine and Rituximab (BR) in subjects with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
EudraCT number 2012-000600-15
Protocol number PCI-32765CLL3001
Sponsor Janssen-Cilag International NV, Belgie
Indications Oncology
Diagnosis chronic lymphatic leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2012
Date of approval by Institute (SÚKL) 5.9.2012
Date of approval by EC 19.9.2012
Date of initiation CT in ČR 14.2.2013
Date of ending CT in ČR 4.4.2019
Sites FNKV, Odd. klinické hematologie, Praha 10
VFN,1. interní klinika, Praha 2
FN Brno, Interní hemtatoonkologická klinika, Brno

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