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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
December 2010
NCT00075725Uploaded 04-09-2017
Access via NCI by Request
PDS UID: nci-data-351
High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
Provider Information
Provider Data DescriptionThere are three datasets associated with this publication (NCT00075725-D1, NCT00075725-D2, and NCT00075725-D3): NCT00075725-D3 is the toxicity data observed in the randomized cohorts (steroid and methotrexate).
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
ConditionsAcute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Intervention TypeDrug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug(s)Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Leucovorin Calcium
Drug: Prednisone
Total Enrolled3154
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Active Comparator
Arm III - Experimental
Arm IV - Experimental
Secondary IDNCI-2009-00301
PubMed (PMID)33496745
29284596
26590194
26265699
26124497
24970932
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Switzerland
Age Range1 Year to 30 Years (Child, Adult)
Files: NCT00075725-D3
Data DictionaryNCT00075725-D3-Data-Dictionary.pdf
DATANCT00075725-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00075725-D2
Data DictionaryNCT00075725-D2-Data-Dictionary.pdf
DATANCT00075725-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00075725-D1
Data DictionaryNCT00075725-D1-Data-Dictionary.pdf
DATANCT00075725-D1-Dataset.csv
OTHERREADME.pdf
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