Trial Number




Participant Age Range

90 days to 4 years

Participant Gender


Enrolling Participants



Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

In contrast to other contemporary treatment approaches to pediatric leukemia, current protocols for Acute Myeloid Leukemia in children with Down syndrome (DS AML) lack a risk-adapted stratification of treatment intensity. As a result, cycles of high-dose chemotherapy continue to be administered to all patients with DS AML. The majority of patients with DS AML have prognostically very favorable disease and do not benefit from high-intensity chemotherapy. Maximizing dose intensity has proved a successful strategy for the treatment of AML in the general pediatric population; however, intensive AML therapy protocols were optimized in the non-DS pediatric population and have shown adverse effects on this specific population of DS AML. Therefore, COG has pursued the rational development of treatment protocols specific for DS AML.


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