A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
NCT ID: NCT00947856
Last Updated: 2017-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2009-07-31
2013-03-31
Brief Summary
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Detailed Description
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* Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
* Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BV Retreatment
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
brentuximab vedotin
Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
BV Extension
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
brentuximab vedotin
Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
Interventions
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brentuximab vedotin
Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CD30-positive hematologic malignancy.
* At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.
Exclusion Criteria
6 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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Laurie Grove, PA-C
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
Stanford Cancer Center
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Loyola University Medical Center - Cardinal Bernadin Cancer Center
Maywood, Illinois, United States
St. Francis Medical Group Oncology & Hematology Specialists
Indianapolis, Indiana, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
The John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
NYU Clinical Cancer Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Charles A. Sammons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center /The University of Texas
Houston, Texas, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, United States
Hopital Saint-Louis/Service d'Hematologie
Paris, Cedex 10, France
Countries
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References
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Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. doi: 10.1186/1756-8722-7-24.
Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.
Other Identifiers
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2010-019932-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SGN35-006
Identifier Type: -
Identifier Source: org_study_id
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