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Detail of the clinical trial

Title of the trial A randomized, open-label safety and efficacy study of ibrutinib in pediatric and young adult patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma
EudraCT number 2016-000259-28
Protocol number 54179060LYM3003
Sponsor Janssen-Cilag International, NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Indications Hemato-oncology
Diagnosis non-Hodgkin lymphoma
Population in clinical trial Infants and Toddlers (28 days - 23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2016
Date of approval by Institute (SÚKL) 3.8.2016
Date of approval by EC
Date of initiation CT in ČR 4.1.2018
Date of ending CT in ČR 14. 7. 2021
Notice
Sites Fakultní nemocnice v Motole, Klinika dětské hematologie a onkologie, V Úvalu 84, 150 06 Praha 5
Fakultní nemocnice Brno, Klinika dětské onkologie, Černopolní 9, 662 63 Brno (discontinued)

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