A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
NCT ID: NCT00866047
Last Updated: 2017-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2009-03-31
2016-06-30
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 (IV) infusion
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented anaplastic lymphoma kinase (ALK) status.
* 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 and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
* Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
* 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.
* Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
* 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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Dana Kennedy, PharmD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Palo Alto, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Baylor Sammons Cancer Center / Texas Oncology
Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
UZ Gasthuisberg
Leuven, , 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
Christie Hospital NHS
Manchester, , United Kingdom
Countries
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References
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Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.
Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3.
Other Identifiers
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2008-006035-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SG035-0004
Identifier Type: -
Identifier Source: org_study_id
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