A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma (NCT02979522)
An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (15 items).
Location: Children's Hospital Colorado — Aurora, Colorado
Age range: 5 Years to 17 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:
- Nodular lymphocyte predominant HL.
- Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML.
- Any sensory or motor peripheral neuropathy.
- Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.
- Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks before the first study protocol therapy.
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of AVD.
- Known human immunodeficiency virus positive.
- Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection, as determined by hepatitis B DNA or hepatitis C RNA, respectively, in blood.
- Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Use of any strong or listed moderate cytochrome P450 (CYP) 3A4 inhibitors less than (\<) 2 weeks before the first dose of protocol therapy (please refer to the Study Manual for an example list of prohibited CYP3A4 inhibitors).
- Any of the following cardiovascular conditions or values within 6 months before the first dose of protocol therapy:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (14 Sites)
- Children's Hospital Colorado — Aurora, Colorado
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Hospital Sao Rafael S/A — Salvador, Estado de Bahia
- Jardim das Americas — Paranã,
- INCA - Instituto Nacional de Cancer — Rio de Janeiro,
- GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer — São Paulo,
- ICr - Instituto da Crianca - HCFMUSP — São Paulo,
- Hospital Santa Marcelina — São Paulo,
- Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer — Florence,
- Fondazione IRCCS Policlinico San Matteo — Pavia,
- Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia — Roma,
- Azienda Ospedaliera Citta della Salute e della Scienza di Torino — Torino,
- NHO Nagoya Medical Center — Nagoya, Aichi-ken
- St. Marianna University School of Medicine Hospital — Kawasaki-shi, Kanagawa
💰 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.
More studies in Hodgkin Disease
- Tissue Collection for Studies of Lymph Cancer — Bethesda, Maryland
- Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL) — Houston, Texas
- Administration of T Lymphocytes for Prevention of Relapse of Lymphomas — Chapel Hill, North Carolina
- Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies — Milwaukee, Wisconsin
Explore by condition: All Hodgkin Disease 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.