Title: An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
The purpose of this study is to assess the safety, tolerability, and antitumor activity, as well as recommended dose of brentuximab vedotin in combination with a multiagent chemotherapy regimen, doxorubicin, vinblastine, and dacarbazine, in pediatric participants with advanced stage, newly diagnosed classical CD30+ Hodgkin lymphoma.
This study will assess the safety, tolerability, and antitumor 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 Hodgkin lymphoma.
The study will enroll approximately 55 evaluable participants and will be conducted in 2 phases. Phase 1 will enroll up to 12 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 approximately 55, including participants treated at recommended dose in phase 1. Participants will be enrolled into 2 dose cohorts: (1) brentuximab vedotin 48 mg/m^2 or (2) 36 mg/m^2 in combination with doxorubicin, vinblastine, and dacarbazine.
Phase 1 has completed enrollment and Phase 2 is now open for enrollment.
This multicenter trial is being conducted in United States, Italy, Brazil, Japan, Taiwan, Singapore, and Hong Kong. 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 until death or study closure or a maximum of 2 years after enrollment of the last participant.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02979522.
Status: This study is open and recruiting patients as of May 27, 2019.
This study is sponsored by Millennium Pharmaceuticals, Inc.
Clinicaltrials.gov. A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma. NCT02979522. https://clinicaltrials.gov/ct2/show/NCT02979522. Accessed June 24, 2019.