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Detail of the clinical trial

Title of the trial A Phase 3 Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission
EudraCT number 2016-001643-39
Protocol number 2215-CL-0302
Sponsor Astellas Pharma Global Development, Inc. , 1 Astellas Way, Northbrook, IL 60062, United States of America
Indications Hemato-oncology
Diagnosis Acute Myeloid Leukemia (AML)
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2016
Date of approval by Institute (SÚKL) 20.2.2017
Date of approval by EC 8.12.2016
Date of initiation CT in ČR 10.9.2018
Date of ending CT in ČR 7.10.2020
Sites Faklultni nemocnice Ostrava,Klinika hematoonkologie,17.listopadu 1790,Ostrava - Poruba,708 52

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