Woman and Man
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Extract
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.
Inclusion criteria
- Treatment of children and young adults with molecular relapse of acute myeloid leukemia
- (AML) after first complete remission (CR1)