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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
December 2022
NCT02883049Uploaded 04-27-2021
Access via NCI by Request
PDS UID: nci-data-466
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations
Provider Information
Provider Data DescriptionNCT02883049-D1-Dataset Description: There are three data submissions associated with PMID 30545921. This dataset provides the information for generating the consort diagram of patient enrollment. It includes all patients who enrolled on AALL1131 up to 12/31/2017.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, 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) and giving the drugs in different doses and in different combinations may kill more cancer cells.
ConditionsB Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
Central Nervous System Leukemia
Testicular Leukemia
Intervention TypeDrug: Clofarabine
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Hydrocortisone Sodium Succinate
Other: Laboratory Biomarker Analysis
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: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Daunorubicin Hydrochloride
Drug: Hydrocortisone Sodium Succinate
Drug: Etoposide
Drug: Clofarabine
Drug: Dasatinib
Total Enrolled5937
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionDS HR B-ALL (RER) - Experimental
DS HR B-ALL (SER) - Experimental
Group I Arm A (HR B-ALL) - Experimental
Group I Arm B (HR B-ALL) (CLOSED 03/19/2018) - Experimental
Group II Arm A (VHR B-ALL - Control Arm) - Active Comparator
Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) - Experimental
Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014) - Experimental
Group III PH-like predicted TKI-sensitive kinase mutation - Experimental
Secondary IDNCI-2011-03797
PubMed (PMID)32496902
Collaborator(s)N/A
Region(s)United States
Australia
Canada
Ireland
New Zealand
Puerto Rico
Switzerland
Age Range1 Year to 31 Years (Child, Adult)
Files: NCT02883049-D1
Data DictionaryNCT02883049-D1-Data-Dictionary_2.pdf
DATANCT02883049-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT02883049-D2
Data DictionaryNCT02883049-D2-Data-Dictionary_3.pdf
DATANCT02883049-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT02883049-D3
Data DictionaryNCT02883049-D3-Data-Dictionary_2.pdf
DATANCT02883049-D3-Dataset.csv
OTHERREADME.pdf
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