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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
October 2020
NCT02339740Uploaded 09-28-2023
Access via NCI by Request
PDS UID: nci-data-525
A Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid
Provider Information
Provider Data DescriptionNCT02339740-D1: There are 2 datasets associated with the PMID 34762093: NCT02339740-D1 through NCT02339740-D2. This dataset, NCT02339740-D1 containing patient characteristics, laboratory findings, and outcome for eligible Acute Promyelocytic Leukemia in children enrolled on the AAML1331 clinical trial. Data for this publication?s historical control, AAML0631, can be found in NCT00866918-D1 and NCT00866918-D2.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.
ConditionsAcute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Intervention TypeDrug: Arsenic Trioxide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Idarubicin
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Tretinoin
Drug(s)Drug: Arsenic Trioxide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Idarubicin
Drug: Mitoxantrone Hydrochloride
Drug: Tretinoin
Total Enrolled158
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionTreatment (tretinoin, arsenic trioxide, chemotherapy) - Experimental
Secondary IDNCI-2014-02266
PubMed (PMID)34762093
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Saudi Arabia
Age Range12 Months to 21 Years (Child, Adult)
Files: NCT02339740-D1
Data DictionaryNCT02339740-D1-Data-Dictionary_0.pdf
DATANCT02339740-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT02339740-D2
Data DictionaryNCT02339740-D2-Data-Dictionary_0.pdf
DATANCT02339740-D2-Dataset.csv
OTHERREADME.pdf
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