A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

• Status: Completed
• Trial end date: 2020-04-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients with HL who have received ASCT in the previous 30-45 days

• Patients at high risk of residual HL post ASCT

• Histologically-confirmed HL

• ECOG of 0 or 1

• Adequate organ function

Exclusion Criteria:

• Previous treatment with brentuximab vedotin

• Previously received an allogeneic transplant

• Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT

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

• Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents