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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