A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell

In brief

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

Key facts

Study ID

NCT01421667

Run by

Seagen Inc.

People needed

176

Starts

2011-08-01

Expected to finish

2015-06-01

Last updated by the study team

2016-11-28

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically-confirmed NHL (DLBCL only for Parts B and C)
• Relapsed or refractory disease following at least 1 prior systemic therapy
• Measurable disease of at least 1.5 cm as documented by CT
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

You may not qualify if…

• History of another primary invasive malignancy that has not been in remission for at least 3 years
• Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
• B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
• Known cerebral/meningeal disease

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope — Duarte, California, United States
• PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists — Oxnard, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Cancer Specialists of North Florida - St. Augustine — Saint Augustine, Florida, United States
• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Minnesota Oncology Hematology P.A. — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• NYU Clinical Cancer Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic, The — Cleveland, Ohio, United States
• Willamette Valley Cancer and Research / USOR — Eugene, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• St. Francis Hospital — Greenville, South Carolina, United States
• Texas Oncology - Medical City Dallas — Dallas, Texas, United States
• Charles A. Sammons Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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