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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2001-09
NCT01230983Uploaded 09-15-2018
Access via NCI by Request
PDS UID: nci-data-356
Intensive Treatment For T-CELL Acute Lymphoblastic Leukemia and Advanced Stage Lymphoblastic Non-Hodgkin's Lymphoma: A Pediatric Oncology Group Phase III Study
Provider Information
Provider Data DescriptionDataset 2 Description: NCT01230983-D2 is the subset of the 239 patients with data on Troponin levels. These data were used in the mixed model analyses to assess the effect of Dexrazoxane on the probability of an elevated troponin concentration during treatment.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.
ConditionsCardiac Toxicity
Leukemia
Lymphoma
Intervention TypeDrug: asparaginase
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy
Drug(s)Drug: asparaginase
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Drug: dexrazoxane hydrochloride
Drug: leucovorin calcium
Total Enrolled573
RandomizationNon Randomized
Blinding MethodDouble
Arms InterventionTreatment 1: (No HD MTX / No Zinecard) - Experimental
Treatment 2: (No HD MTX / Zinecard) - Active Comparator
Treatment 3: (HD MTX / No Zinecard) - Active Comparator
Treatment 4: (HD MTX / Zinecard) - Active Comparator
Secondary IDU10CA030969
PubMed (PMID)20459861
20016527
Collaborator(s)National Cancer Institute (NCI)
Region(s)N/A
Age Range21 Years and younger (CHILD, ADULT)
Files: NCT01230983-D2
Data DictionaryNCT01230983-D2-Data-Dictionary.pdf
DATANCT01230983-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT01230983-D1
Data DictionaryNCT01230983-D1-Data-Dictionary.pdf
DATANCT01230983-D1-Dataset.csv
OTHERREADME.pdf
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