Detail of the clinical trial
| Title of the trial | Randomized, double-blind, placebo-controlled phase 3 stuy of Ibrutinib,a Bruton´s Tyrosine Kinase (BTK) inhibitor, in combination with Bendamustine and Rituximab (BR) in subjects with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma |
|---|---|
| EudraCT number | 2012-000600-15 |
| Protocol number | PCI-32765CLL3001 |
| Sponsor | Janssen-Cilag International NV, Belgie |
| Indications | Oncology |
| Diagnosis | chronic lymphatic leukemia |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2012 |
| Date of approval by Institute (SÚKL) | 5.9.2012 |
| Date of approval by EC | 19.9.2012 |
| Date of initiation CT in ČR | 14.2.2013 |
| Date of ending CT in ČR | 4.4.2019 |
| Notice | |
| Sites |
FNKV, Odd. klinické hematologie, Praha 10 VFN,1. interní klinika, Praha 2 FN Brno, Interní hemtatoonkologická klinika, Brno |
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