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NCTN: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) under the Age of 4 Years (AAML0431)
Study ID: AAML0431
NCT Number: NCT00369317
Children's Oncology Group (COG)
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) under the Age of 4 Years (AAML0431)
Trial Description: This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Clinical data presented in the following publication(s):
- PMID 28389462
Disease type(s):
- Hematopoietic Neoplasm/Leukemia - Acute Myeloid Leukemia
- Hematopoietic Neoplasm/Leukemia - Myelodysplastic Syndrome
Clinical Dataset(s) included:
- NCT00369317-D1 (PMID 28389462): NCT00369317-D1 is the only dataset associated with AAML0431's primary publication 28389462. The dataset contains the CONSORT flow of patient enrollment, baseline characteristics, adverse events, MRD, cytogenetics, and primary outcome analyses for patients on AAML0431 as reported in the manuscript. Also, data for patients on A2971 are provided in order to compare brief baseline characteristics and outcome to patients on AAML0431.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)