Clinical Trials

Inclusion Criteria:

• Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])
• Patients with previously untreated de novo AML who meet the criteria for AML with ≥ 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification
• Patients with cytopenias and/or bone marrow blasts who do not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts are eligible if they meet the criteria for a diagnosis of myelodysplastic syndrome (MDS)
• Patients with a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention), who:
  • Are > 8 weeks since resolution of transient myeloproliferative disease (TMD) with ≥ 5% blasts, OR
  • Patients sho have an increasing blast count (≥ 5%) in serial bone marrow aspirates performed at least 4 weeks apart
• Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD
• There are no minimal organ function requirements for enrollment on this study
  • Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
• Each patient's parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met

Exclusion Criteria:

• Patients with promyelocytic leukemia (French-American-British [FAB] M3)
• Prior therapy
  • Patients ≤ 30 days from the last dose of cytarabine used for treatment