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

Completed · Phase 2

Conditions studied: Disease, Hodgkin

In brief

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.

Key facts

Study ID

NCT00848926

Run by

Seagen Inc.

People needed

102

Starts

2009-02-01

Expected to finish

2015-05-01

Last updated by the study team

2017-03-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of California at Los Angeles — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Loyola University Medical Center Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Baylor Sammons Cancer Center — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States
• UZ Gasthuisberg — Leuven, Belgium
• Cliniques Universitaires UCL de Mont-Goddine — Yvoir, Belgium
• B.C Cancer Agency — Vancouver, British Columbia, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Institut Paoli Calmettes — Marseille, France
• Hospital Saint Louis — Paris, France

Full record on ClinicalTrials.gov

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