Detail of the clinical trial

Title of the trial A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator?s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation
EudraCT number 2018-002443-28
Protocol number ACE-CL-311/D8221C00001
Sponsor Acerta Pharma B.V., Kloosterstraat 9, Oss 5349 AB, Netherlands
Indications 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) 2019
Date of approval by Institute (SÚKL) 31.7.2019
Date of approval by EC 15.5.2019
Date of initiation CT in ČR 10.9.2019
Date of ending CT in ČR
Notice
Sites Fakultní nemocnice Ostrava,Hematoonkologická klinika,17. listopadu 1790/5,Ostrava-Poruba,708 52
Fakultní nemocnice Olomouc,Hematoonkologická klinika,I. P. Pavlova 185/66 ,Olomouc ,779 00
Fakultní nemocnice Plzeň,Hematologicko-onkologické oddělení,Alej Svobody 80,Plzeň-Lochotín,304 60
Fakultní nemocnice Hradec Kralové,Hematoonkologická klinika ,Sokolska 581,Hradec Kralové,500 05
Fakultní nemocnice Vinohrady,Hematoonkologická klinika ,Šrobárova 1150/50 ,Praha 10,100 34
Fakultní nemocnice Brno ,Hematoonkologická klinika,Jihlavská 20 ,Brno,625 00

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