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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
June 2015
NCT00866918Uploaded 02-09-2020
Access via NCI by Request
PDS UID: nci-data-386
Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation
Provider Information
Provider Data DescriptionNCT00866918-D2 These data provide specific incidence of adverse events in interest. This dataset is necessary to construct Table 3 (Toxicities Reported in >10% of Patients During a Course of Therapy) on the manuscript.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. 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 Promyelocytic Leukemia With PML-RARA
Myeloid Neoplasm
Intervention TypeDrug: Arsenic Trioxide
Drug: Cytarabine
Other: Diagnostic Laboratory Biomarker Analysis
Drug: Idarubicin
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Mitoxantrone Hydrochloride
Drug: Tretinoin
Drug(s)Drug: Arsenic Trioxide
Drug: Cytarabine
Drug: Idarubicin
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Mitoxantrone Hydrochloride
Drug: Tretinoin
Total Enrolled106
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (standard risk, combination chemotherapy) - Experimental
Arm II (high risk, combination chemotherapy) - Experimental
Secondary IDNCI-2011-01904
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Age Range2 Years to 21 Years (Child, Adult)
Files: NCT00866918-D2
Data DictionaryNCT00866918-D2-Data-Dictionary.pdf
DATANCT00866918-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00866918-D1
Data DictionaryNCT00866918-D1-Data-Dictionary.pdf
DATANCT00866918-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00866918-D3
Data DictionaryNCT00866918-D3-Data-Dictionary_1.pdf
DATANCT00866918-D3-Dataset.csv
OTHERREADME.pdf
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