A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

• Phase: Phase 2
• 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 relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.

• Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.

• Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.

• At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

• Previous treatment with brentuximab vedotin.

• Previously received an allogeneic transplant.

• Congestive heart failure, Class III or IV, by the New York Heart Association criteria.

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

• Known cerebral/meningeal disease.