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Type(s) of Cancer
Leukemia/Lymphoma, Myelodysplastic Syndrome (MDS)
Study Phase
Phase 3
Study Completion Date
2013-12-01
NCT00369317Uploaded 12-06-2018
Access via NCI by Request
PDS UID: nci-data-384
The Treatment of Down Syndrome Children With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Under the Age of 4 Years
Provider Information
Provider Data DescriptionNCT00369317-D1 is the only dataset associated with this publication. 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.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsChildhood Acute Basophilic Leukemia
Childhood Acute Eosinophilic Leukemia
Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
Childhood Acute Myelomonocytic Leukemia (M4)
Childhood Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Intervention TypeDrug: asparaginase
Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: thioguanine
Drug: etoposide
Other: laboratory biomarker analysis
Drug(s)Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: thioguanine
Drug: etoposide
Total Enrolled205
RandomizationNa
Blinding MethodNone
Arms InterventionTreatment (combination chemotherapy) - Experimental
Secondary IDNCI-2009-00318
PubMed (PMID)28389462
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Puerto Rico
Age Range4 Years and younger (CHILD)
Files: NCT00369317-D1
Data DictionaryNCT00369317-D1-Data-Dictionary.pdf
DATANCT00369317-D1-Dataset.csv
OTHERREADME.pdf
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