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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2017-09-30
NCT00557193Uploaded 01-12-2024
Access via NCI by Request
PDS UID: nci-data-530
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)
Provider Information
Provider Data DescriptionD1: NCT00557193-D1 Dataset Description: There are 3 data submissions (NCT00557193-D1, -D2 and -D3) for PMID 33623141. This dataset, NCT00557193-D1, provides the information for generating Figure 1 of consort diagram of patient enrollment, information for generating Table 1 of KMT2A patient characteristics, information for Event-free survival /Disease-free survival / Overall survival analysis, Cumulative incidence of treatment failure, relapse and death, including Figure 2, 3, 4 , Table 4 and ?Remission induction and treatment failure by risk group? section. It provides the information of Table 3 of Disease-free Events (Treatment failure, Relapse, and Death). There is one row for each patient enrolled. The data cutoff is 03/31/2019.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
ConditionsAcute Lymphoblastic Leukemia
Acute Undifferentiated Leukemia
Childhood T Acute Lymphoblastic Leukemia
Intervention TypeDrug: Asparaginase
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Procedure: Echocardiography
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Lestaurtinib
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Procedure: Multigated Acquisition Scan
Drug: Pegaspargase
Other: Pharmacological Study
Drug: Prednisone
Drug: Therapeutic Hydrocortisone
Drug: Vincristine Sulfate
Drug(s)Drug: Asparaginase
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Drug: Pegaspargase
Drug: Prednisone
Drug: Therapeutic Hydrocortisone
Drug: Vincristine Sulfate
Drug: Lestaurtinib
Total Enrolled218
RandomizationNon Randomized
Blinding MethodNone
Arms InterventionArm A (standard risk MLL-G) - Experimental
Arm B (IR/HR MLL-R chemotherapy) - Active Comparator
Arm C (IR/HR MLL-R chemotherapy and lestaurtinib) - Experimental
Secondary IDNCI-2009-00313
PubMed (PMID)32414848
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Age Range1 Year and younger (CHILD)
Files: NCT00557193-D1
Data DictionaryNCT00557193-D1-Data-Dictionary_0.pdf
DATANCT00557193-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00557193-D2
Data DictionaryNCT00557193-D2-Data-Dictionary_0.pdf
DATANCT00557193-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00557193-D3
Data DictionaryNCT00557193-D3-Data-Dictionary_0.pdf
DATANCT00557193-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00557193-D4
Data DictionaryNCT00557193-D4-Data-Dictionary.pdf
DATANCT00557193-D4-Dataset_0.csv
OTHERREADME.pdf
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