Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Seattle Genetics, Inc.

Collaborator: Millennium Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: brentuximab vedotin

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting