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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 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
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
Region(s)United States Australia Canada Ireland New Zealand Puerto Rico Switzerland
Age Range1 Year to 31 Years (Child, Adult)