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Detail of the clinical trial

Title of the trial A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects with Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation.
EudraCT number 2015-000344-42
Protocol number AG-221-AML-004
Sponsor Celgene Corporation, 86 Morris Avenue, Summit NJ 0790, United States of America
Indications Hemato-oncology
Diagnosis Myeloid 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) 3.3.2016
Date of approval by EC 11.2.2016
Date of initiation CT in ČR 5.9.2016
Date of ending CT in ČR 16. 9. 2021
Sites Fakultní nemocnice Hradec Králové,IV. interní hematologická klinika,Sokolská 581,Hradec Králové,500 05 (discontinued)
Fakultní nemocnice Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno,625 00 (discontinued)
Všeobecná fakultní nemocnice v Praze,I. interní klinika - klinika hematologie,U Nemocnice 2,Prague 2,128 00

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