drugset / Trial / NCT02112916

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

NCT02112916

Phase 3 Active not recruiting 847 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Timeline

Start
2014-10-04
Primary completion
2020-03-31
Completion
2026-09-16

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intrathecal
Background Daunorubicin Small molecule Intravenous
Background Dexamethasone Small molecule Oral
Background Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Hydrocortisone Other / unclassified Intrathecal
Background Ifosfamide Small molecule Intravenous
Background Leucovorin Small molecule Oral
Background MERCAPTOPURINE ANHYDROUS Small molecule Oral
Background Methotrexate Small molecule Intrathecal
Background Pegaspargase Protein / enzyme biologic Intravenous
Background Thioguanine Small molecule Oral
Background Vincristine Small molecule Intravenous