Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

Inclusion Criteria:

• Histopathological diagnosis of classical Hodgkin lymphoma
• Failed standard front-line therapy
• Measurable disease of at least 1.5 cm as documented by radiographic technique
• Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion Criteria:

• Received prior salvage therapy, including radiotherapy
• Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
• Concurrent use of other investigational agents