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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2019-03-31
NCT01190930Uploaded 02-07-2024
Access via NCI by Request
PDS UID: nci-data-532
Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Provider Information
Provider Data DescriptionThere are 2 data submissions (NCT01190930-D1, and -D2) for PMID 33411585. This dataset, NCT01190930-D1, contains the information on patient enrollment, patient characteristics, event-free survival/disease-free survival/overall survival analysis, cumulative incidence of relapse, SMN and death, induction death, induction failure, and sites of relapses by pulse frequency, oral methotrexate dose and AR maintenance arm presented in Figures 2, 3, 4, A1, A2, A3 and Tables 2, 3, A5. There is one row for each patient enrolled. The data cutoff is 06/30/2019.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
ConditionsAcute Lymphoblastic Leukemia
Adult B Lymphoblastic Lymphoma
Ann Arbor Stage I B Lymphoblastic Lymphoma
Ann Arbor Stage II B Lymphoblastic Lymphoma
Childhood B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Childhood B Lymphoblastic Lymphoma
Down Syndrome
Hypodiploid B Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive
Intervention TypeDrug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug(s)Drug: Dexamethasone
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Pegaspargase
Drug: Thioguanine
Total Enrolled9350
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A (risk-adapted chemotherapy) - Experimental
Arm B (risk-adapted chemotherapy) - Experimental
Arm B-LLy (4-week cycle maintenance) - Experimental
Arm C (risk-adapted chemotherapy) - Experimental
Arm D (risk-adapted chemotherapy) - Experimental
Arm LR-C (risk-adapted chemotherapy) - Experimental
Arm LR-M (risk-adapted chemotherapy) - Experimental
Arm SR DS (12-week cycle maintenance) - Experimental
Secondary IDNCI-2011-02599
PubMed (PMID)33411585
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Ireland
New Zealand
Puerto Rico
Switzerland
Age Range1 Year to 30 Years (CHILD, ADULT)
Files: NCT01190930-D1
Data DictionaryNCT01190930-D1-Data-Dictionary_1.pdf
DATANCT01190930-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01190930-D2
Data DictionaryNCT01190930-D2-Data-Dictionary_1.pdf
DATANCT01190930-D2-Dataset_3.csv
OTHERREADME.pdf
Files: NCT01190930-D3
Data DictionaryNCT01190930-D3-Data-Dictionary_1.pdf
DATANCT01190930-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01190930-D4
Data DictionaryNCT01190930-D4-Data-Dictionary_1.pdf
DATANCT01190930-D4-Dataset.csv
OTHERREADME.pdf
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