drugset / Trial / NCT02166463

Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma

NCT02166463

Phase 3 Active not recruiting 600 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupSingle-blindTreatment

Summary

This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, 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. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.

Timeline

Start
2015-03-19
Primary completion
2021-12-31
Completion
2026-10-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bleomycin Unknown Intravenous
Subject Brentuximab Vedotin Monoclonal antibody Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Methylprednisolone Other / unclassified Intravenous
Background Prednisone Other / unclassified Oral
Background Vincristine Small molecule Intravenous