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Trial record 2 of 9 for:    brentuximab vedotin | Phase 3

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100502
Recruitment Status : Active, not recruiting
First Posted : April 9, 2010
Results First Posted : November 11, 2015
Last Update Posted : March 19, 2019
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Disease, Hodgkin Drug: brentuximab vedotin Drug: placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : August 2014
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Brentuximab vedotin
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Drug: brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
Other Names:
  • SGN-35
  • Adcetris

Placebo Comparator: Placebo
placebo every 3 weeks by IV infusion
Drug: placebo
Every 21 days by IV infusion

Primary Outcome Measures :
  1. Progression-free Survival by Independent Review [ Time Frame: Up to approximately 4 years ]
    Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to approximately 10 years ]
    Time from date of randomization to date of death due to any cause

  2. Incidence of Adverse Events or Laboratory Abnormalities [ Time Frame: Up to 12 months ]
  3. Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin [ Time Frame: Up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01100502

  Hide Study Locations
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United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
University of California at San Francisco
San Francisco, California, United States, 94134
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago Section of Hematology/Oncology Lymphoma Program
Chicago, Illinois, United States, 60637-1470
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
New York University Cancer Institute
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic, The
Cleveland, Ohio, United States, 44195
James Cancer Hospital / Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University / Center for Hematologic Malignancies
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Temple Bone Marrow Transplant Program
Philadelphia, Pennsylvania, United States, 19111
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
Sofia, Bulgaria, 1527
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
Sofia, Bulgaria, 1756
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie
Praha, Czechia, 10034
Vseobecni fakultni nemocnice v Prahe-I. interni klinika
Praha, Czechia, 128 08
CHU Nantes - Hopital Hotel Dieu Service Hematologie
Nantes, France, 44000
Service des Maladies du Sang / Hospital Saint Louis
Paris, France, 75475 Cedex 10
CHU Bordeaux Hopital Haut-Levaque
Pessac, France, 33600
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, France, 76038
University Hospital of Cologne
Koeln, Germany, 50924
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
Budapest, Hungary, 1097
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
Debrecen, Hungary, 4004
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
Pecs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, Hungary, 6720
Instituto di Ematologia ed Oncologia Medica
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Istituto Nazionale dei Tumori
Milano, Italy, 20133
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach
Gliwice, Poland, 44-101
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
Katowice, Poland, 40-032
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin, Poland, 20-950
MTZ Clinical Research Sp. z o.o.
Warsaw, Poland, 02-106
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
Warsaw, Poland, 02-766
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, Poland, 02-781
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
Targu Mures, Judetul Mures, Romania, 540136
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie
Timisoara, Judetul Timis, Romania, 300011
Fundeni Clinical Institute
Bucharest, Romania, 022328
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
Bucharest, Romania, 022328
Russian Federation
Burdenko Central Military Clinical Hospital
Moscow, Russian Federation, 105229
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
Moscow, Russian Federation, 115478
Federal Medical Biophysical Center n.a. A.I. Burnazyan
Moscow, Russian Federation, 123098
Gematologicheskj nauchnyj centr RAMN
Moscow, Russian Federation, 125167
Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii
Novosibirsk, Russian Federation, 630099
Respublikanskaja bol'nica im. V.A. Baranova
Petrozavodsk, Russian Federation, 185019
Leningradskaja oblastnaja klinicheskaja bol'nica
St. Petersburg, Russian Federation, 194291
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
St. Petersburg, Russian Federation, 197022
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation, 197101
Gorodskaya bol'nica #31
St. Petersburg, Russian Federation, 197110
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High
St. Petersburg, Russian Federation, 197341
Sverdlovskaja oblastnaja klinicheskaja bol'nica #1
Yekaterinburg, Russian Federation, 620102
Klinicki centar Srbije, Klinika za hematologiju
Belgrad, Serbia, 11000
Vojnomedicinska akademija, Klinika za hematologiju
Belgrad, Serbia, 11000
Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju
Novi Sad, Serbia, 21000
Complejo Hospitalano de Navarra Servicio Hematologia
Pamplona, Navarra, Spain, 31130
Hospital de la Santa Creu i Sant Paul
Barcelona, Spain, 08025
Hospital Clinic i Provincial Servicio Hematologia
Barcelona, Spain, 08036
Centro Oncologico MD Anderson
Madrid, Spain, 28033
Hospital Universitaro de Salamanca
Salamanca, Spain, 37007
United Kingdom
Addenbrooke`s Hospital
Cambridge, United Kingdom, CB2 0QQ
St James University Hospital
Leeds, United Kingdom, LS9 7TF
Guy`s Hospital Haematology Department, 4th Floor Southwark Wing
London, United Kingdom, SE1 9RT
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
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Study Director: Julie Lisano, PharmD Seattle Genetics, Inc.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Seattle Genetics, Inc. Identifier: NCT01100502     History of Changes
Other Study ID Numbers: SGN35-005
2009-016947-20 ( EudraCT Number )
First Posted: April 9, 2010    Key Record Dates
Results First Posted: November 11, 2015
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Seattle Genetics, Inc.:
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Drug Therapy
Hematologic Diseases
Monomethylauristatin E
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs