A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
NCT ID: NCT01421667
Last Updated: 2016-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2011-08-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brentuximab vedotin+rituximab
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
rituximab
375 mg/m2 every 3 weeks by IV infusion
Brentuximab vedotin
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Interventions
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brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
rituximab
375 mg/m2 every 3 weeks by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
6 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Corinna Palanca-Wessels, MD, PhD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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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
Texas Oncology-Southwest Fort Worth
Fort Worth, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Texas Oncology - Seton Williamson
Round Rock, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Swedish Cancer Institute Medical Oncology
Edmonds, Washington, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Countries
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References
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Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. doi: 10.1182/blood-2013-12-542142. Epub 2014 Mar 20.
Jacobsen ED, Sharman JP, Oki Y, Advani RH, Winter JN, Bello CM, Spitzer G, Palanca-Wessels MC, Kennedy DA, Levine P, Yang J, Bartlett NL. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. Blood. 2015 Feb 26;125(9):1394-402. doi: 10.1182/blood-2014-09-598763. Epub 2015 Jan 8.
Bartlett NL, Smith MR, Siddiqi T, Advani RH, O'Connor OA, Sharman JP, Feldman T, Savage KJ, Shustov AR, Diefenbach CS, Oki Y, Palanca-Wessels MC, Uttarwar M, Li M, Yang J, Jacobsen ED. Brentuximab vedotin activity in diffuse large B-cell lymphoma with CD30 undetectable by visual assessment of conventional immunohistochemistry. Leuk Lymphoma. 2017 Jul;58(7):1607-1616. doi: 10.1080/10428194.2016.1256481. Epub 2016 Nov 20.
Other Identifiers
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SGN35-012
Identifier Type: -
Identifier Source: org_study_id