drugset / Trial / NCT02686346

Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE

NCT02686346

NaSingle-groupOpen-labelTreatment

Summary

This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen. The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.

Timeline

Start
2016-03
Primary completion
2018-10-31
Completion
2021-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 0.8 mg/kg
Subject Brentuximab Vedotin Monoclonal antibody 1.2 mg/kg
Subject Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg
Background Carboplatin Small molecule 800 mg
Background Etoposide Small molecule 100 mg/m2
Background Ifosfamide Small molecule 5 g

Indications