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) Male Female Patients |
| 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 |
| Notice | |
| Sites | Faklultni nemocnice Ostrava,Klinika hematoonkologie,17.listopadu 1790,Ostrava - Poruba,708 52 |
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