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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2024-06-30
NCT02521493Uploaded 03-29-2023
Access via NCI by Request
PDS UID: nci-data-511
Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
Provider Information
Provider Data DescriptionNCT02521493-D1 Dataset There are 2 datasets associated with PMID 34320162, NCT02521493-D1 through NCT02521493-D2. The NCT02521493-D1 dataset is a patient level dataset (single row per patient) containing patient characteristics, laboratory findings, and outcome for eligible myeloid leukemia in children with Down syndrome (ML-DS) enrolled on the AAML1531 clinical trial.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAcute Myeloid Leukemia
Down Syndrome
Myelodysplastic Syndrome
Myeloid Leukemia Associated With Down Syndrome
Myeloproliferative Neoplasm
Intervention TypeDrug: Asparaginase
Drug: Asparaginase Erwinia chrysanthemi
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Drug: Thioguanine
Drug(s)Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Drug: Thioguanine
Drug: Asparaginase
Drug: Asparaginase Erwinia chrysanthemi
Drug: Mitoxantrone Hydrochloride
Total Enrolled280
RandomizationNon Randomized
Blinding MethodNone
Arms InterventionArm A (standard risk) - Experimental
Arm B (high risk) - Experimental
Secondary IDNCI-2015-00324
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Saudi Arabia
Age Range91 Days to 3 Years (CHILD)
Files: NCT02521493-D1
Data DictionaryNCT02521493-D1-Data-Dictionary_2.pdf
DATANCT02521493-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT02521493-D2
Data DictionaryNCT02521493-D2-Data-Dictionary_1.pdf
DATANCT02521493-D2-Dataset_1.csv
OTHERREADME.pdf
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