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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 Myelodyspl...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-002388-13

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 myelomonocyctic 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

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Extrait

The primary objective is to assess the treatment effect on response rate (MDS: CR, PR, or marrow CR; JMML: either cCR or cPR) at Cycle 3 Day 28 and to compare against standard therapy using a matched-pairs analysis with historical data.

Critère d'inclusion

  • newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT)

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