drugset / Trial / NCT02979522

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

NCT02979522

Phase 1/2 Active not recruiting 59 enrolled Takeda
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2017-09-06
Primary completion
2020-05-05
Completion
2029-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 36 mg/m2 Intravenous
Subject Brentuximab Vedotin Monoclonal antibody 48 mg/m2 Intravenous
Background Dacarbazine Small molecule 375 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Background Vinblastine Small molecule 6 mg/m2 Intravenous