Detail of the clinical trial

Title of the trial Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
EudraCT number 2019-002217-19
Protocol number M19-708
Sponsor AbbVie Deutschland GmbH & Co. KG, Knollstrasse, Ludwigshafen 67061, Germany
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) 2019
Date of approval by Institute (SÚKL) 3.2.2020
Date of approval by EC
Date of initiation CT in ČR 23.6.2020
Date of ending CT in ČR
Sites FN Ostrava,Klinika hematoonkologie,17. listopadu 1790,Ostrava,708 52
Ústav hematologie a krevní transfúze,,U nemocnice 2094/1,Praha 2,128 20
FN Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno,625 00

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