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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