A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Brentuximab Vedotin; Rituximab

Criteria

Inclusion Criteria:

• Histologically-confirmed NHL (DLBCL only for Parts B and C)

• Relapsed or refractory disease following at least 1 prior systemic therapy

• Measurable disease of at least 1.5 cm as documented by CT

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

• History of another primary invasive malignancy that has not been in remission for at least 3 years

• Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides

• B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy

• Known cerebral/meningeal disease