A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma

A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma

The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.

Inclusion Criteria:

• Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
• Measurable disease of at least 1.5 cm
• Eastern Cooperative Oncology Group performance status <3

Exclusion Criteria:

• History of another primary malignancy that has not been in remission for at least 3 years
• Known cerebral/meningeal disease