A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
NCT ID: NCT00848926
Last Updated: 2017-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2009-02-28
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brentuximab vedotin
brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous infusion
Interventions
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brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
12 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Abraham Fong, MD, PhD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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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
Centre Henri Becquerel
Rouen, , France
Instituto di Ematologia ed Oncologia Medica
Bologna, , Italy
Countries
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References
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Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.
Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.
Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.
Other Identifiers
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2008-006034-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SG035-0003
Identifier Type: -
Identifier Source: org_study_id
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