Detail of the clinical trial

Title of the trial A Phase 3 Open-Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplant (HSCT) Consolidation.
EudraCT number 2013-004890-28
Protocol number AC220-007
Sponsor Daiichi Sankyo Inc., 399 Thornall Street, Edison, NJ 08837, United States of America
Indications Hemato-oncology
Diagnosis Myeloid leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2015
Date of approval by Institute (SÚKL) 14.4.2016
Date of approval by EC 20.1.2016
Date of initiation CT in ČR 30.3.2017
Date of ending CT in ČR
Notice
Sites Fakultní nemocnice Olomouc,Hematoonkologická klinika,I.P. Pavlova 6,Olomouc,775 20
Fakultní nemocnice Hradec Kralove,IV. Interní hematologická klinika,Sokolska 581,Hradec Králove,500 05
Fakultní nemocnice Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno,625 00

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