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Detail of the clinical trial

Title of the trial A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous Leukemia
EudraCT number 2015-000221-37
Protocol number Pevonedistat-2001
Sponsor Millennium Pharmaceuticals, Inc., 40 Landsdowne Street,Cambridge, MA 02139, United States of America
Indications Hemato-oncology
Diagnosis Myelogenous Leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2015
Date of approval by Institute (SÚKL) 22.2.2016
Date of approval by EC 6.1.2016
Date of initiation CT in ČR 3.8.2016
Date of ending CT in ČR 3.10.2018
Sites Ústav Hematologie a krevní transfúze, U Nemocnice 2094/1,Praha 2,128 20
Fakultní nemocnice Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno,625 00
Fakultní nemocnice Královské Vinohrady,Interní hematologická klinika,Šrobárova 1150/50,Praha 10,100 34

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