Detail of the clinical trial

Title of the trial A Randomized, Multicenter, Open-label, Phase 3 Study of theBruton?s Tyrosine Kinase Inhibitor PCI-32765 versusChlorambucil in Patients 65 Years or Older with Treatment-naiveChronic Lymphocytic Leukemia or Small LymphocyticLymphoma
EudraCT number 2012-003967-23
Protocol number PCYC-1115-CA
Sponsor Pharmacyclics, Incorporated,995 East Arques Avenue,Sunnyvale, CA,94085-4521
Indications Oncology
Diagnosis Chronic lymphocytic Leukemia
Population in clinical trial Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2012
Date of approval by Institute (SÚKL) 7.2.2013
Date of approval by EC 7.2.2013
Date of initiation CT in ČR 5.4.2013
Date of ending CT in ČR 23.7.2015
Notice
Sites Fakultní nemocnice Brno,Interní hematoonkologická klinika,Jihlavská 20,Brno,625 00
Fakultní nemocnice Plzeň,Hematologicko ? onkologické oddělení,Alej Svobody 80,Plzeň - Lochotín,304 60
Fakultní nemocnice Hradec Králové,IV.interní hematologická klinika,Sokolská 581 ,Hradec Králové,500 05

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