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Detail of the clinical trial

Title of the trial A Phase 3, Randomized, Controlled, Open-Label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
EudraCT number 2017-000318-40
Protocol number Pevonedistat-3001
Sponsor Takeda Development Center Americas, Inc., 95 Hayden Avenue, Lexington, Massachusetts 02421, United States of America
Indications Hemato-oncology
Diagnosis Acute Myeloid Leukemia; MDS, CMML
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2017
Date of approval by Institute (SÚKL) 15.12.2017
Date of approval by EC 2.11.2017
Date of initiation CT in ČR 4.6.2018
Date of ending CT in ČR 23.2.2022
Sites Fakultní nemocnice Hradec Králové,IV. interní hematologická klinika,Sokolská 581,Hradec Králové,500 05
Všeobecná fakultní nemocnice v Praze,I. interní klinika - klinika hematologie,U Nemocnice 2,Praha,128 08
Fakultní nemocnice Královské Vinohrady,Interní hematologická klinika,Šrobárova 1150/50,Praha,100 34

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