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

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

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.

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.