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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01100502
First received: April 6, 2010
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Disease, Hodgkin
Drug: brentuximab vedotin
Drug: placebo
Phase 3

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Until study closure ] [ Designated as safety issue: No ]
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of anti-therapeutic antibodies (ATA) to SGN-35 [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Enrollment: 329
Study Start Date: April 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
brentuximab vedotin
Drug: brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
Other Name: SGN-35
Active Comparator: 2
placebo
Drug: placebo
Every 21 days by IV infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100502

  Hide Study Locations
Locations
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
St. 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
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29615
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
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
Bulgaria
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
Sofia, Bulgaria, 1527
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
Sofia, Bulgaria, 1756
Czech Republic
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Kralove, Czech Republic, 500 05
Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie
Praha, Czech Republic, 10034
Vseobecni fakultni nemocnice v Prahe-I. interni klinika
Praha, Czech Republic, 128 08
France
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
Germany
University Hospital of Cologne
Koeln, Germany, 50924
Hungary
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
Italy
Instituto di Ematologia ed Oncologia Medica
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Istituto Nazionale dei Tumori
Milano, Italy, 20133
Poland
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
Romania
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
Gematologicheskj nauchnyj centr RAMN
Moscow, Russian Federation, 125167
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
Burdenko Central Military Clinical Hospital
Moscow, Russian Federation, 105229
Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii
Novosibirsk, Russian Federation, 630099
Respublikanskaja bol'nica im. V.A. Baranova
Petrozavodsk, Russian Federation, 185019
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High
St. Petersburg, Russian Federation, 197341
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
St. Petersburg, Russian Federation, 197022
Gorodskaya bol'nica #31
St. Petersburg, Russian Federation, 197110
Leningradskaja oblastnaja klinicheskaja bol'nica
St. Petersburg, Russian Federation, 194291
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation, 197101
Sverdlovskaja oblastnaja klinicheskaja bol'nica #1
Yekaterinburg, Russian Federation, 620102
Serbia
Klinicki centar Srbije, Klinika za hematologiju
Beograd, Serbia, 11000
Vojnomedicinska akademija, Klinika za hematologiju
Beograde, Serbia, 11000
Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju
Novi Sad, Serbia, 21000
Spain
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.
Investigators
Study Director: Naomi Hunder, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01100502     History of Changes
Other Study ID Numbers: SGN35-005
Study First Received: April 6, 2010
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Drug Therapy
Hematologic Diseases
Immunotherapy
Lymphoma
Monomethylauristatin E

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014