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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients with Down Syndrome

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.
Not Available
Phase III
Children
Not Available
6-thioguanine (6-TG), Cytarabine (ARA-C), Daunorubicin (Daunomycin), Etoposide, Intrathecal Cytarabine, L-Asparaginase, Mitoxantrone
Friedman, Debra
International
Vanderbilt University
08-23-2016
Treatment
COGAAML1531
NCT02521493

Eligibility

91 Days
BOTH
NO
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 ** Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis * 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 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR * 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

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 =

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