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Detail of the clinical trial

Title of the trial A randomized, double-blind phase 3 study of vadastuximab talirine (SGN-CD33A) versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML)
EudraCT number 2015-003482-28
Protocol number SGN33A-005
Sponsor Seattle Genetics, Inc.,21823 30th Drive SE,Bothell,WA 98021, United States of America
Indications Hemato-oncology
Diagnosis Acute Myeloid Leukemia
Population in clinical trial Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2016
Date of approval by Institute (SÚKL) 20.5.2016
Date of approval by EC 14.7.2016
Date of initiation CT in ČR 29.12.2016
Date of ending CT in ČR 30.6.2017
Notice
Sites Fakultní nemocnice Ostrava,Klinika hematoonkologie,17. listopadu 1790,Ostrava-Poruba,708 52
Fakultní nemocnice Hradec Králové,IV. Interní hematologická klinika,Sokolská 581,Hradec Králové,50005
Ústav hematologie a krevní transfuze,,U Nemocnice 2094/1,Praha 2,128 20
Fakultní nemocnice Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno,625 00

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