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

Not Recruiting

Trial ID: NCT00848926


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.

Official Title

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

Stanford Investigator(s)


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

   - Known cerebral/meningeal disease.


drug: brentuximab vedotin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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