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A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
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.
A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
- 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.
- 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
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