WHO ICTRP trial
To determine the safety, clinical efficacy, and effect of azacitidine on the…
EUCTR2014-002388-13-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2014-002388-13-ES |
|---|---|
| Public title | To determine the safety, clinical efficacy, and effect of azacitidine on the body,within the body and interactions within the body in children and young adults with newly diagnosed advanced Myelodysplastic Syndromes or Juvenile myelomonocytic leukemia before transplantation of the bone marrow and blood. At the end of the study, the data will be compared to data from an older study of patients with the same diseases. |
| Scientific title | 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… |
| Primary sponsor | Celgene Corporation |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden |
| Conditions | newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT) MedDRA version: 17.1 Level: LLT Classification code 10054439 Term: Juvenile chronic… |
| Interventions | Trade Name: Vidaza 25 mg/ml polvo para suspensión inyectable Product Name: Azacitidina Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: AZACITIDINA CAS Number: 320-67-2 Concentration unit: mg/ml… |
| Registration date | Apr 11, 2014 |
| Target size | 55 |
| Secondary IDs | AZA-JMML-001;2014-002388-13-DE |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: