Last updated on February 2018

A Study of Brentuximab Vedotin + Adriamycin Vinblastine and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma


Brief description of study

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as 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 Study 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 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 in the following 2 dose Cohorts:

Brentuximab vedotin 48 mg/m^2 or 36 mg/m^2 in combination with doxorubicin, vinblastine, and dacarbazine.

This multi-center trial will be conducted in United States (US), Italy, Spain, 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.

Clinical Study Identifier: NCT02979522

Contact Investigators or Research Sites near you

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Takeda Study Registration Call Center

Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia
Roma, Italy
8.2miles
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