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A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
Sponsor: Takeda
Summary
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).
Official title: An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2017-09-06
Completion Date
2029-09-24
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
Brentuximab vedotin
Brentuximab vedotin infusion
Doxorubicin
Doxorubicin infusion
Vinblastine
Vinblastine infusion
Dacarbazine
Dacarbazine infusion
Locations (14)
Children's Hospital Colorado
Aurora, Colorado, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Hospital Sao Rafael S/A
Salvador, Estado de Bahia, Brazil
Jardim das Americas
Paranã, Brazil
INCA - Instituto Nacional de Cancer
Rio de Janeiro, Brazil
GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer
São Paulo, Brazil
ICr - Instituto da Crianca - HCFMUSP
São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, Brazil
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia
Roma, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Italy
NHO Nagoya Medical Center
Nagoya, Aichi-ken, Japan
St. Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, Japan