Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome: A COG Groupwide Phase III Study All patients will first receive a common cycle of induction therapy that includes a continuous infusion of standard-dose cytarabine, bolus infusion of daunorubicin and oral 6-thioguanine (TAD). Following interim analysis, patients in the standard risk group (MRD ≤ 0.05% at the end of Induction I) who received reduced intensity therapy consisting of two additional induction cycles of TAD and two cycles of intensification therapy with standard-dose cytarabine and etoposide with the elimination of HD Ara-C were found to have an inferior 2 year event-free survival (EFS) compared to patients who received HD Ara-C on AAML0431. Thus, following amendment 4A, the standard risk arm of this study is permanently closed. Patients enrolled after amendment 4A who are assigned to the standard risk arm after Induction I will be removed from study.