drugset / Trial / NCT02883049

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

NCT02883049

Phase 3 Completed 5949 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This 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.

Timeline

Start
2012-02-29
Primary completion
2022-12-31
Completion
2026-03-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Cytarabine Small molecule Intrathecal
Subject Etoposide Small molecule Intravenous
Subject Hydrocortisone Other / unclassified Intrathecal
Subject Methotrexate Small molecule Intrathecal
Subject dasatinib anhydrous Small molecule Oral
Background Daunorubicin Small molecule Intravenous
Background Dexamethasone Small molecule Oral
Background Doxorubicin Other / unclassified Intravenous
Background Leucovorin Small molecule Oral
Background MERCAPTOPURINE ANHYDROUS Small molecule Oral
Background Pegaspargase Protein / enzyme biologic Intravenous
Background Prednisone Other / unclassified Oral
Background Thioguanine Small molecule Oral
Background Vincristine Small molecule Intravenous