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)
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
2 other identifiers
interventional
329
13 countries
87
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2010
Longer than P75 for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2010
CompletedFirst Posted
Study publicly available on registry
April 9, 2010
CompletedStudy Start
First participant enrolled
April 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2014
CompletedResults Posted
Study results publicly available
November 11, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2020
CompletedMay 14, 2021
April 1, 2021
4.3 years
April 6, 2010
July 31, 2015
April 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival by Independent Review
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 Outcomes (3)
Overall Survival
Up to approximately 10 years
Incidence of Adverse Events or Laboratory Abnormalities
Up to 12 months
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Up to 12 months
Study Arms (2)
Brentuximab vedotin
EXPERIMENTALbrentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Placebo
PLACEBO COMPARATORplacebo every 3 weeks by IV infusion
Interventions
Every 21 days by IV infusion (1.8 mg/kg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
- Millennium Pharmaceuticals, Inc.collaborator
Study Sites (87)
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
University of California at San Francisco
San Francisco, California, 94134, United States
Stanford Cancer Center
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Section of Hematology/Oncology Lymphoma Program
Chicago, Illinois, 60637-1470, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380
Indianapolis, Indiana, 46202, United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21231, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New York University Cancer Institute
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic, The
Cleveland, Ohio, 44195, United States
James Cancer Hospital / Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health and Science University / Center for Hematologic Malignancies
Portland, Oregon, 97239-3098, United States
Temple Bone Marrow Transplant Program
Philadelphia, Pennsylvania, 19111, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29615, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
Sofia, 1527, Bulgaria
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
Sofia, 1756, Bulgaria
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie
Prague, 10034, Czechia
Vseobecni fakultni nemocnice v Prahe-I. interni klinika
Prague, 128 08, Czechia
CHU Nantes - Hopital Hotel Dieu Service Hematologie
Nantes, 44000, France
Service des Maladies du Sang / Hospital Saint Louis
Paris, 75475 Cedex 10, France
CHU Bordeaux Hopital Haut-Levaque
Pessac, 33600, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, 76038, France
University Hospital of Cologne
Cologne, 50924, Germany
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
Budapest, 1097, Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
Debrecen, 4004, Hungary
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
Pécs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, 6720, Hungary
Instituto di Ematologia ed Oncologia Medica
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, 16132, Italy
Istituto Nazionale dei Tumori
Milan, 20133, Italy
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach
Gliwice, 44-101, Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
Katowice, 40-032, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-510, Poland
Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin, 20-950, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
Warsaw, 02-766, Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
Târgu Mureş, Mureș County, 540136, Romania
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie
Timișoara, Timiș County, 300011, Romania
Fundeni Clinical Institute
Bucharest, 022328, Romania
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
Bucharest, 022328, Romania
Burdenko Central Military Clinical Hospital
Moscow, 105229, Russia
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
Moscow, 115478, Russia
Federal Medical Biophysical Center n.a. A.I. Burnazyan
Moscow, 123098, Russia
Gematologicheskj nauchnyj centr RAMN
Moscow, 125167, Russia
Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii
Novosibirsk, 630099, Russia
Respublikanskaja bol'nica im. V.A. Baranova
Petrozavodsk, 185019, Russia
Leningradskaja oblastnaja klinicheskaja bol'nica
Saint Petersburg, 194291, Russia
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
Saint Petersburg, 197022, Russia
St. Petersburg Pavlov State Medical University
Saint Petersburg, 197101, Russia
Gorodskaya bol'nica #31
Saint Petersburg, 197110, Russia
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High
Saint Petersburg, 197341, Russia
Sverdlovskaja oblastnaja klinicheskaja bol'nica #1
Yekaterinburg, 620102, Russia
Klinicki centar Srbije, Klinika za hematologiju
Belgrade, 11000, Serbia
Vojnomedicinska akademija, Klinika za hematologiju
Belgrade, 11000, Serbia
Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju
Novi Sad, 21000, Serbia
Complejo Hospitalano de Navarra Servicio Hematologia
Pamplona, Navarre, 31130, Spain
Hospital de la Santa Creu i Sant Paul
Barcelona, 08025, Spain
Hospital Clinic i Provincial Servicio Hematologia
Barcelona, 08036, Spain
Centro Oncologico MD Anderson
Madrid, 28033, Spain
Hospital Universitaro de Salamanca
Salamanca, 37007, Spain
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Guy's Hospital Haematology Department, 4th Floor Southwark Wing
London, SE1 9RT, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (2)
Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19.
PMID: 25796459RESULTMoskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.
PMID: 30266774DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Seagen Inc.
Study Officials
- STUDY DIRECTOR
Julie Lisano, PharmD
Seagen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 6, 2010
First Posted
April 9, 2010
Study Start
April 30, 2010
Primary Completion
August 31, 2014
Study Completion
April 27, 2020
Last Updated
May 14, 2021
Results First Posted
November 11, 2015
Record last verified: 2021-04