Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
NCT ID: NCT01874054
Last Updated: 2019-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2013-06-30
2018-02-20
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 + Bendamustine
Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine
90 mg/m2 on Days 1 and 2 of 3-week cycles
Interventions
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brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine
90 mg/m2 on Days 1 and 2 of 3-week cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failed standard front-line therapy
* Measurable disease of at least 1.5 cm as documented by radiographic technique
* Eastern Cooperative Oncology Group performance status less than or equal to 2
Exclusion Criteria
* Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
* Concurrent use of other investigational agents
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Josephson, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Stanford Cancer Center
Stanford, California, United States
Oncology Institute of Hope & Innovation, The
Whittier, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
Jewish Hospital, The
Cincinnati, Ohio, United States
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, United States
Saint Francis Hospital / Bon Secours
Greenville, South Carolina, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States
Countries
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References
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LaCasce AS, Bociek RG, Sawas A, Caimi P, Agura E, Matous J, Ansell SM, Crosswell HE, Islas-Ohlmayer M, Behler C, Cheung E, Forero-Torres A, Vose J, O'Connor OA, Josephson N, Wang Y, Advani R. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018 Jul 5;132(1):40-48. doi: 10.1182/blood-2017-11-815183. Epub 2018 Apr 27.
Other Identifiers
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SGN35-016
Identifier Type: -
Identifier Source: org_study_id
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