A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
Trial ID or NCT#
NCT00848926
Status
NOT RECRUITING
Purpose
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:
- - 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.
Investigator(s)
Sandra Horning
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov