Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma (NCT02166463)
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (9 items).
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: 2 Years to 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with nodular lymphocyte-predominant HL
- Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
- Patients who are pregnant; (since fetal toxicities and teratogenic effects have been noted for several of the study drugs, a negative pregnancy test is required for female patients of childbearing potential)
- Lactating females who plan to breastfeed
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 30 days after the last dose of chemotherapy
- Patients known to be positive for human immunodeficiency virus (HIV) are not eligible
- Patients who have received any previous chemotherapy or radiation therapy are not eligible
- Patients who received systemic corticosteroids within 28 days of enrollment on this protocol, except as specified, are not eligible
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (199 Sites)
Showing the first 25 of 199 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- USA Health Strada Patient Care Center — Mobile, Alabama
- Providence Alaska Medical Center — Anchorage, Alaska
- Banner Children's at Desert — Mesa, Arizona
- Phoenix Childrens Hospital — Phoenix, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Kaiser Permanente Downey Medical Center — Downey, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Loma Linda University Medical Center — Loma Linda, California
- Miller Children's and Women's Hospital Long Beach — Long Beach, California
- Children's Hospital Los Angeles — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Valley Children's Hospital — Madera, California
- Kaiser Permanente-Oakland — Oakland, California
- Children's Hospital of Orange County — Orange, California
- Sutter Medical Center Sacramento — Sacramento, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Rady Children's Hospital - San Diego — San Diego, California
- Naval Medical Center -San Diego — San Diego, California
- Santa Barbara Cottage Hospital — Santa Barbara, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California
- Children's Hospital Colorado — Aurora, Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Ann Arbor Stage IIB Hodgkin Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.