A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

In brief

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.

Key facts

Study ID

NCT00866047

Run by

Seagen Inc.

People needed

58

Starts

2009-03-01

Expected to finish

2016-06-01

Last updated by the study team

2017-03-22

Who can join

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

You may qualify if…

• Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
• Documented anaplastic lymphoma kinase (ALK) status.
• 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 and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
• Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
• 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.
• Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
• Known cerebral/meningeal disease.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Baylor Sammons Cancer Center / Texas Oncology — Dallas, Texas, United States
• MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States
• UZ Gasthuisberg — Leuven, 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
• Centre Henri Becquerel — Rouen, France
• Christie Hospital NHS — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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