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Two parts study, the first part is to determine the dose of azacitidine and the second part is to evaluate the effect of azacitidine compared to no treatment, in children and young adults following a ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-002172-92

Two parts study, the first part is to determine the dose of azacitidine and the second part is to evaluate the effect of azacitidine compared to no treatment, in children and young adults following a molecular relapse of acute myeloid leukemia after the first complete remission

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Extrait

Safety Run-in Part -To establish a safe and tolerable dose of azacitidine to be used in the randomized part of the study. Randomized Part -To evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after CR1 when compared to no treatment with regard to the progression-free rate (PFR) at Day 84 (±4 days) postrandomization.

Critère d'inclusion

  • Treatment of children and young adults with molecular relapse of acute myeloid leukemia
  • (AML) after first complete remission (CR1)

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