Detail of the clinical trial

Title of the trial A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Na?ve Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
EudraCT number 2016-003900-30
Protocol number M16-043
Sponsor AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Indications Hemato-oncology
Diagnosis Acute Myeloid Leukemia
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2017
Date of approval by Institute (SÚKL) 12.6.2017
Date of approval by EC 28.6.2017
Date of initiation CT in ČR 4.9.2017
Date of ending CT in ČR 21.7.2021
Sites Ústav hematologie a krevní transfúze Praha, Transplantační jednotka a JIHeP, U nemocnice 2094/1, 128020 Praha 2
FN Ostrava, Hematoonkologická klinika, 17. listopadu 1790, 708 52 Ostrava
FN Královské Vinohrady Praha, Interní hematologická klinika, Šrobárova 50, 100 34 Praha 10
FN Brno, Interní hematologická a onkologická klinika, Jihlavská 20, 625 00 Brno

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