A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:April 2010
End Date:April 2020

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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate
the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC)
compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following
autologous stem cell transplant (ASCT).


Inclusion Criteria:

- Patients with HL who have received ASCT in the previous 30-45 days

- Patients at high risk of residual HL post ASCT

- Histologically-confirmed HL

- ECOG of 0 or 1

- Adequate organ function

Exclusion Criteria:

- Previous treatment with brentuximab vedotin

- Previously received an allogeneic transplant

- Patients who were determined to have a best clinical response of progressive disease
with salvage treatment immediately prior to ASCT

- History of another primary malignancy that has not been in remission for at least 3
years

- Post ASCT or current therapy with other systemic anti-neoplastic or investigational
agents
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33
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Baltimore, Maryland 21231
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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303 East Superior Street
Chicago, Illinois 60611
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Cleveland, Ohio 44195
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Greenville, South Carolina 29605
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1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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New York, New York 10016
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19111
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Pittsburgh, Pennsylvania 15224
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
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Stanford, California 94305
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