Detail of the clinical trial

Title of the trial A Phase 2, multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics, safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric subjects with newly diagnosed advanced myelodysplastic syndrome or juvenile myelomonocytic leukemia before hematopoietic stem cell transplantation.
EudraCT number 2014-002388-13
Protocol number AZA-JMML-001
Sponsor Celgene Corporation, 86 Morris Avenue, New Jersey 07901, United States of America
Indications Hemato-oncology
Diagnosis leukemia
Population in clinical trial Infants and Toddlers (28 days - 23 months)
Children (2-11 years)
Adolescents (12-17 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2015
Date of approval by Institute (SÚKL) 15.5.2015
Date of approval by EC 4.3.2015
Date of initiation CT in ČR 26.10.2015
Date of ending CT in ČR 10.4.2019
Notice
Sites Fakultní nemocnice Motol,Klinika dětské hematologie a onkologie,V Úvalu 84,Praha,150 06

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