OncRef

Clinical Trial: NCT02166463

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-01

Study Overview

Brief 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.

Official Title

A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults

Conditions

Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin Lymphoma, Childhood Hodgkin Lymphoma, Classic Hodgkin Lymphoma

Intervention / Treatment

  • Biological: Bleomycin Sulfate
  • Drug: Brentuximab Vedotin
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin Hydrochloride
  • Drug: Etoposide
  • Other: Laboratory Biomarker Analysis
  • Drug: Methylprednisolone
  • Other: Pharmacological Study
  • Drug: Prednisone
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Drug: Vincristine Sulfate

Other Study ID Numbers

  • NCI-2014-01223
  • NCI-2014-01223
  • s15-00950
  • AHOD1331
  • AHOD1331
  • U10CA180886

Start Date (Actual)

2015-03-19

Primary Completion Date (Actual)

2021-12-31

Study Completion Date (Estimated)

2026-10-03

Enrollment (Actual)

600

Study Type

Interventional

Phase

Phase 3