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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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)

Eligibility Criteria

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.


Sandra Horning

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Cancer Clinical Trials Office