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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Myelodysplastic Syndrome, Pediatric Leukemia
Phase III
Children
Chemotherapy - cytotoxic
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

Not Available
Not Available
Not Available
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: * Patient 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 * Patient 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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