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.