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Detail of the clinical trial

Title of the trial A Randomized, Open-label, Controlled Phase 3 Adaptive Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
EudraCT number 2014-002476-92
Protocol number 20120215
Sponsor Amgen Inc, One Amgen Center Drive,Thousand Oaks, California, 91320, United States of America
Indications Hemato-oncology
Diagnosis Lymphoblastic Leukemia (ALL)
Population in clinical trial Infants and Toddlers (28 days - 23 months)
Children (2-11 years)
Adolescents (12-17 years)
Year of receiving the request to Institute (SÚKL) 2015
Date of approval by Institute (SÚKL) 26.5.2015
Date of approval by EC 24.6.2015
Date of initiation CT in ČR 9.3.2016
Date of ending CT in ČR
Sites Fakultní nemocnice v Motole,Klinika dětské hematologie a onkologie UK 2. LF a FN Motol,V Úvalu 84,Praha 5,150 06

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