Detail of the clinical trial
| Title of the trial | A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE? Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) |
|---|---|
| EudraCT number | 2013-000536-10 |
| Protocol number | 00103311 |
| Sponsor | Amgen Inc.,One Amgen Center Drive,Thousand Oaks,CA 91320-1799 |
| Indications | Hemato-oncology |
| Diagnosis | Leukemia |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2013 |
| Date of approval by Institute (SÚKL) | 24.10.2013 |
| Date of approval by EC | 7.11.2013 |
| Date of initiation CT in ČR | 14.1.2014 |
| Date of ending CT in ČR | 3.3.2016 |
| Notice | |
| Sites |
Fakultní nemocnice Hradec Králové,IV. Interní hematologická klinika,Sokolská 581,Hradec Králové,500 05 Fakultní nemocnice Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno,625 00 Ústav hematologické a krevní transfuze,Klinický úsek ,U Nemocnice 2,Praha 2,128 20 Fakultní nemocnice Královské Vinohrady,Interní hematologická klinika,Šrobárova 50,Praha 10,100 34 |
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