PURPOSE:
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.AGES ELIGIBLE FOR STUDY: 91 Days to 3 Years
ELIGIBILITY CRITERIA
Inclusion Criteria:
o Are > 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR
o Patients sho have an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart
o Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
Exclusion Criteria:
DETAILED DESCRIPTION:
PRIMARY OBJECTIVES:
· To determine the 2-year event-free-survival (EFS) for children with standard risk Down syndrome (DS) acute myeloid leukemia (AML) (minimal residual disease [MRD]-negative after one cycle of induction therapy) after elimination of high dose (HD) Ara-C (cytarabine) from the treatment regimen.
· To determine the 2-year EFS for children with high risk DS AML (MRD-positive after one cycle of induction therapy) after intensification of treatment equivalent to that used for high risk AML in children without DS..
Study Type: Interventional
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
For more information contact:
Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati OH 45229-3039
Phone: 513-636-2799