A Pivotal Open-Label Trial of Brentuximab Vedotin for 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.