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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
August 2013
NCT00372593Uploaded 03-24-2021
Access via NCI by Request
PDS UID: nci-data-460
A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
Provider Information
Provider Data DescriptionAs of November 2019, there is one dataset associated with this publication (PMID 31113932). The D3 dataset is a patient level dataset which contains patient characteristics, genotypes for the SNP of interest, cytogenetic mutation, and outcome analyses for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML0531 clinical trial.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.
ConditionsLeukemia
Intervention TypeDrug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: gemtuzumab ozogamicin
Drug: mitoxantrone hydrochloride
Drug(s)Drug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: mitoxantrone hydrochloride
Drug: gemtuzumab ozogamicin
Total Enrolled1070
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome - Active Comparator
Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome - Experimental
Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome - Active Comparator
Secondary IDCOG-AAML0531
PubMed (PMID)22378848
25092781
34596937
33080007
28883080
27133823
23471307
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range29 Years and younger (Child, Adult)
Files: NCT00372593-D3
Data DictionaryNCT00372593-D3-Data-Dictionary_2.pdf
DATANCT00372593-D3-Dataset_2.csv
OTHERREADME.pdf
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