Detail of the clinical trial

Title of the trial A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton?s Tyrosine Kinase Inhibitor Ibrutinib in Combination with Obinutuzumab versus Chlorambucil in Combination with Obinutuzumab in Subjects with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
EudraCT number 2014-002069-31
Protocol number PCYC-1130-CA
Sponsor Pharmacyclics, LLC, 995 East Arques Avenue, Sunnyvale,CA 94085-4521, United States of America
Indications Hemato-oncology
Diagnosis chronic lymphocytic leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2014
Date of approval by Institute (SÚKL) 12.1.2015
Date of approval by EC 17.12.2014
Date of initiation CT in ČR
Date of ending CT in ČR
Sites FN Brno,Interní hematologická a onkologická klinika ,Jihlavská 20,Brno ,625 00 (discontinued)
Fakultní nemocnice Hradec Králové ,IV . Interní hematologická klinika ,Sokolská 581,Hradec Králové,500 05

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