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Disease, HodgkinPhase 3NCT01100502

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 Phase 3 study testing brentuximab vedotin in people with Disease, Hodgkin, run by Seagen Inc. at 87 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Disease, Hodgkin
What is being tested?
brentuximab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
329 participants
Where
87 sitesin 13 countries
Study dates
30 Apr 2010to 27 Apr 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

87 sites in 13 countries.

87 sites in 13 countries

United States32 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Johns Hopkins Medical Center

    Baltimore, Maryland, 21231

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Section of Hematology/Oncology Lymphoma Program

    Chicago, Illinois, 60637-1470

  • Cleveland Clinic, The

    Cleveland, Ohio, 44195

  • James Cancer Hospital / Ohio State University

    Columbus, Ohio, 43210

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Karmanos Cancer Institute / Wayne State University

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Cancer Center of the Carolinas

    Greenville, South Carolina, 29615

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380

    Indianapolis, Indiana, 46202

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • New York University Cancer Institute

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Temple Bone Marrow Transplant Program

    Philadelphia, Pennsylvania, 19111

  • Western Pennsylvania Cancer Institute

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health and Science University / Center for Hematologic Malignancies

    Portland, Oregon, 97239-3098

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California at San Francisco

    San Francisco, California, 94134

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Cancer Center

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

Russia12 sites

  • Burdenko Central Military Clinical Hospital

    Moscow, 105229

  • Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

    Moscow, 115478

  • Federal Medical Biophysical Center n.a. A.I. Burnazyan

    Moscow, 123098

  • Gematologicheskj nauchnyj centr RAMN

    Moscow, 125167

  • Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii

    Novosibirsk, 630099

  • Respublikanskaja bol'nica im. V.A. Baranova

    Petrozavodsk, 185019

  • Leningradskaja oblastnaja klinicheskaja bol'nica

    Saint Petersburg, 194291

  • Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

    Saint Petersburg, 197022

  • St. Petersburg Pavlov State Medical University

    Saint Petersburg, 197101

  • Gorodskaya bol'nica #31

    Saint Petersburg, 197110

  • Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High

    Saint Petersburg, 197341

  • Sverdlovskaja oblastnaja klinicheskaja bol'nica #1

    Yekaterinburg, 620102

Other trials in Russia

Poland9 sites

  • Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach

    Gliwice, 44-101

  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego

    Katowice, 40-032

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

    Lodz, 93-510

  • Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20-950

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-106

  • Klinika Hematologii, Instytut Hematologii i Transfuzjologii

    Warsaw, 02-766

  • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

France5 sites

  • CHU Nantes - Hopital Hotel Dieu Service Hematologie

    Nantes, 44000

  • Service des Maladies du Sang / Hospital Saint Louis

    Paris, 75475 Cedex 10

  • CHU Bordeaux Hopital Haut-Levaque

    Pessac, 33600

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

    Rouen, 76038

Other trials in France

Spain5 sites

  • Hospital de la Santa Creu i Sant Paul

    Barcelona, 08025

  • Hospital Clinic i Provincial Servicio Hematologia

    Barcelona, 08036

  • Centro Oncologico MD Anderson

    Madrid, 28033

  • Complejo Hospitalano de Navarra Servicio Hematologia

    Pamplona, Navarre, 31130

  • Hospital Universitaro de Salamanca

    Salamanca, 37007

Other trials in Spain

Hungary4 sites

  • Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

    Budapest, 1097

  • Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

    Debrecen, 4004

  • Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

    Pécs

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

    Szeged, 6720

Other trials in Hungary

Romania4 sites

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

    Bucharest, 022328

  • Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

    Târgu Mureş, Mureș County, 540136

  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie

    Timișoara, Timiș County, 300011

Other trials in Romania

United Kingdom4 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • St James University Hospital

    Leeds, LS9 7TF

  • Guy's Hospital Haematology Department, 4th Floor Southwark Wing

    London, SE1 9RT

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Czechia3 sites

  • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

    Hradec Králové, 500 05

  • Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie

    Prague, 10034

  • Vseobecni fakultni nemocnice v Prahe-I. interni klinika

    Prague, 128 08

Other trials in Czechia

Italy3 sites

  • Instituto di Ematologia ed Oncologia Medica

    Bologna, 40138

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Istituto Nazionale dei Tumori

    Milan, 20133

Other trials in Italy

Serbia3 sites

  • Klinicki centar Srbije, Klinika za hematologiju

    Belgrade, 11000

  • Vojnomedicinska akademija, Klinika za hematologiju

    Belgrade, 11000

  • Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju

    Novi Sad, 21000

Other trials in Serbia

Bulgaria2 sites

  • Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

    Sofia, 1527

  • Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

    Sofia, 1756

Other trials in Bulgaria

Germany1 site

  • University Hospital of Cologne

    Cologne, 50924

Other trials in Germany

About this study

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

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).

Being tested
brentuximab vedotin, placebo
Keywords
Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, Monomethylauristatin E
Medical subject headings
Hodgkin Disease, Hematologic Diseases, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brentuximab vedotinDrug

    Also called SGN-35, Adcetris

    Every 21 days by IV infusion (1.8 mg/kg)

  • placeboDrug

    Every 21 days by IV infusion

Study groups in NCT01100502
Study groupRoleWhat they receive
Brentuximab vedotinExperimentalbrentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Receives: Drug: brentuximab vedotin
PlaceboPlacebo comparatorplacebo every 3 weeks by IV infusion
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to approximately 4 years

Secondary outcomes (3)

  1. Overall Survival

    Time from date of randomization to date of death due to any cause

    Measured: Up to approximately 10 years

  2. Incidence of Adverse Events or Laboratory Abnormalities

    Measured: Up to 12 months

  3. Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2010 (estimated)
  2. Study start30 Apr 2010
  3. Primary completion31 Aug 2014
  4. Study completion27 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01100502
Sponsor's protocol ID
SGN35-005
Other IDs
2009-016947-20, 2009
Status last verified
Apr 2021
First submitted
6 Apr 2010
Last updated
14 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • 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.

    PubMed 25796459

  • Moskowitz 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.

    PubMed 30266774

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing brentuximab vedotin in people with Disease, Hodgkin, run by Seagen Inc. at 87 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Russia, Poland, France, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival by Independent Review (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01100502, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.

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