Spots Global Cancer Trial Database for A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
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Trial Identification
Brief Title: A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
Official Title: An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
Study ID: NCT02979522
Conditions
Study Description
Brief 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).
Detailed Description: The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat pediatric participants who have advanced stage, newly diagnosed, classical CD30+ HL. This study will assess the safety, tolerability, and anti-tumor activity, as well as recommended dose of brentuximab vedotin in combination with a multiagent chemotherapy regimen that is based on a current standard of care (SOC) first-line treatment regimen for newly diagnosed HL. The study will enroll approximately 55 evaluable participants. The study will be conducted in 2 phases, Phase 1 and Phase 2. Phase 1 study will enroll at least 6 participants to determine the recommended dose. Once the recommended dose is identified additional participants will be enrolled into phase 2 so that the total number of evaluable participants will be at least 55, including participants treated at recommended dose in Phase 1. Participants will be enrolled to the following initial dose cohort with an option to explore a reduced dose cohort at 36 mg/m\^2 if needed: • Brentuximab vedotin 48 mg/m\^2 in combination with doxorubicin, vinblastine, and dacarbazine. This multi-center trial will be conducted in the United States, Italy, Brazil and Japan. The overall time to participate in this study is approximately 55 months, including the follow-up period. Participants will be followed for a maximum of 30 days following the last dose of protocol therapy for a follow-up assessment and will be followed for survival and disease status every 12 weeks for 12 months, and then every 24 weeks until death or study closure or for up to 2 years from the date of the last participant enrolled.
Eligibility
Minimum Age: 5 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Colorado, Aurora, Colorado, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Hospital Sao Rafael S/A, Salvador, Bahia, Brazil
Jardim das Americas, Parana, , Brazil
INCA - Instituto Nacional de Cancer, Rio de Janeiro, , Brazil
GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer, Sao Paulo, , Brazil
ICr - Instituto da Crianca - HCFMUSP, Sao Paulo, , Brazil
Hospital Santa Marcelina, Sao Paulo, , Brazil
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer, Firenze, , 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-shi, Aichi-Ken, Japan
St. Marianna University School of Medicine Hospital, Kawasaki-shi, Kanagawa-Ken, Japan
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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