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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2016-03
NCT00381680Uploaded 03-05-2024
Access via NCI by Request
PDS UID: nci-data-539
Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
Provider Information
Provider Data DescriptionNCT00381680-D1: There is 1 dataset associated with the PMID 32001530. This dataset, NCT00381680-D1, provides the information presented in all tables, figures, and numbers in the manuscript. It includes all patients who enrolled on COG study AALL0433. There is one row for each patient enrolled. The data cutoff is 06/30/2018.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic 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) and giving the drugs in different ways and different doses may kill more cancer cells..
ConditionsB-cell Childhood Acute Lymphoblastic Leukemia
L1 Childhood Acute Lymphoblastic Leukemia
L2 Childhood Acute Lymphoblastic Leukemia
Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
Intervention TypeDrug: vincristine sulfate
Drug: prednisone
Drug: doxorubicin hydrochloride
Drug: pegaspargase
Drug: cytarabine
Drug: methotrexate
Drug: dexamethasone
Drug: etoposide
Drug: cyclophosphamide
Drug: leucovorin calcium
Biological: filgrastim
Drug: asparaginase
Drug: mercaptopurine
Drug(s)Drug: vincristine sulfate
Drug: prednisone
Drug: doxorubicin hydrochloride
Drug: pegaspargase
Drug: cytarabine
Drug: methotrexate
Drug: dexamethasone
Drug: etoposide
Drug: cyclophosphamide
Drug: leucovorin calcium
Drug: asparaginase
Drug: mercaptopurine
Total Enrolled275
RandomizationRandomized
Blinding MethodNone
Arms InterventionRegimen A: Standard vincristine dosing - Active Comparator
Arm B: Randomized High Dose Vincristine regimen - Experimental
Secondary IDNCI-2009-00306
PubMed (PMID)32001530
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Switzerland
Age Range1 Year to 29 Years (CHILD, ADULT)
Files: NCT00381680-D1
Data DictionaryNCT00381680-D1-Data-Dictionary_1.pdf
DATANCT00381680-D1-Dataset_2.csv
OTHERREADME.pdf
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