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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Bleomycin; Brentuximab Vedotin; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Vinblastine

Criteria

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