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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