Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: acute myeloid leukemia | Down Syndrome
  • Age: Between 0 - 3 Years
  • Gender: Male or Female

Inclusion Criteria

Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])

Patient has one of the following:

- Patients has previously untreated de novo AML and meets the criteria for AML with >= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification

-Patients has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS)

- Patients has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention)

- Patients who 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

Exclusion Criteria

Patients with promyelocytic leukemia

 Prior therapy

Patients =< 30 days from the last dose of cytarabine used for treatment of TMD

Recruitment Status


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If you need help finding a study or have any questions, please contact us at inhealth@iu.edu or by phone at (888) 264-0005.