Detail of the clinical trial

Title of the trial A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
EudraCT number 2019-002089-11
Protocol number CMBG453B12301
Sponsor Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland
Indications Hemato-oncology
Diagnosis Chronic Myelomonocytic Leukemia-2
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2020
Date of approval by Institute (SÚKL) 20.3.2020
Date of approval by EC
Date of initiation CT in ČR 30.6.2020
Date of ending CT in ČR
Sites Všeobecné fakultní nemocnice,I. Interní klinika - klinika hematologie,U nemocnice 499/2,Praha 2 ,128 08
Ústav hematologie a krevní transfuze, U Nemocnice 1,Praha 2 ,128 20
Fakultní nemocnice Brno,Interní hematologická a onkologická klinika,Jihlavská 20,Brno ,625 00

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