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)

April 22, 2021 updated by: Seagen Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

329

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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:
  • Adcetris
  • SGN-35
PLACEBO_COMPARATOR: Placebo
placebo every 3 weeks by IV infusion
Drug: placebo
Every 21 days by IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to approximately 10 years
Time from date of randomization to date of death due to any cause
Up to approximately 10 years
Incidence of Adverse Events or Laboratory Abnormalities
Time Frame: Up to 12 months
Up to 12 months
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Director: Julie Lisano, PharmD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2010

Primary Completion (ACTUAL)

August 31, 2014

Study Completion (ACTUAL)

April 27, 2020

Study Registration Dates

First Submitted

April 6, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (ESTIMATE)

April 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-005
  • 2009-016947-20 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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