Status:
COMPLETED
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Disease, Hodgkin
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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 Hodg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00848926
Start Date
February 1 2009
End Date
May 1 2015
Last Update
March 13 2017
Active Locations (27)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
3
University of California at Los Angeles
Los Angeles, California, United States, 90095
4
Stanford University Medical Center
Palo Alto, California, United States, 94305