Detail of the clinical trial
| Title of the trial | A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE? antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia |
|---|---|
| EudraCT number | 2010-018314-75 |
| Protocol number | MT103-203 |
| Sponsor | Amgen Research (Munich) GmbH,Staffelseestraße 2,Munich,81477 |
| Indications | Hemato-oncology |
| Diagnosis | lymphoblastic 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) | 29.5.2013 |
| Date of approval by EC | 15.5.2013 |
| Date of initiation CT in ČR | 18.12.2013 |
| Date of ending CT in ČR | 1.3.2019(17.12.2018 |
| Notice | |
| Sites |
Ústav hematologie a krevní transfuze,NA,U Nemocnice 1,Praha 2,120 00 Fakultní nemocnice Brno,Interní hematoonkologická klinika,Jihlavská 20,Brno,625 00 |
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