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)
- Registration Number
- NCT01100502
- Lead Sponsor
- Seagen 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 329
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo placebo every 3 weeks by IV infusion Brentuximab vedotin brentuximab vedotin brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
- Primary Outcome Measures
Name Time Method Progression-free Survival by Independent Review 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
Name Time Method Overall Survival Up to approximately 10 years Time from date of randomization to date of death due to any cause
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin Up to 12 months Incidence of Adverse Events or Laboratory Abnormalities Up to 12 months
Trial Locations
- Locations (87)
Cardinal Bernardin Cancer Center / Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Cleveland Clinic, The
🇺🇸Cleveland, Ohio, United States
Western Pennsylvania Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
🇵🇱Lodz, Poland
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
🇧🇬Sofia, Bulgaria
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
🇭🇺Szeged, Hungary
Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach
🇵🇱Gliwice, Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
🇵🇱Katowice, Poland
MTZ Clinical Research Sp. z o.o.
🇵🇱Warsaw, Poland
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
🇷🇺Moscow, Russian Federation
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
🇵🇱Warsaw, Poland
Leningradskaja oblastnaja klinicheskaja bol'nica
🇷🇺St. Petersburg, Russian Federation
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
🇵🇱Warsaw, Poland
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie
🇷🇴Timisoara, Judetul Timis, Romania
Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii
🇷🇺Novosibirsk, Russian Federation
Vojnomedicinska akademija, Klinika za hematologiju
🇷🇸Belgrad, Serbia
Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju
🇷🇸Novi Sad, Serbia
Gematologicheskj nauchnyj centr RAMN
🇷🇺Moscow, Russian Federation
Respublikanskaja bol'nica im. V.A. Baranova
🇷🇺Petrozavodsk, Russian Federation
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
🇷🇺St. Petersburg, Russian Federation
St. Petersburg Pavlov State Medical University
🇷🇺St. Petersburg, Russian Federation
Klinicki centar Srbije, Klinika za hematologiju
🇷🇸Belgrad, Serbia
Burdenko Central Military Clinical Hospital
🇷🇺Moscow, Russian Federation
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
New York University Cancer Institute
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Chicago Section of Hematology/Oncology Lymphoma Program
🇺🇸Chicago, Illinois, United States
Saint Francis Hospital
🇺🇸Greenville, South Carolina, United States
Cancer Center of the Carolinas
🇺🇸Greenville, South Carolina, United States
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
🇧🇬Sofia, Bulgaria
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
🇨🇿Hradec Kralove, Czechia
Service des Maladies du Sang / Hospital Saint Louis
🇫🇷Paris, France
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
🇭🇺Debrecen, Hungary
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
🇭🇺Pecs, Hungary
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
University Hospital of Cologne
🇩🇪Koeln, Germany
Szpital Uniwersytecki w Krakowie
🇵🇱Krakow, Poland
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
🇷🇴Targu Mures, Judetul Mures, Romania
Fundeni Clinical Institute
🇷🇴Bucharest, Romania
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
🇷🇴Bucharest, Romania
Federal Medical Biophysical Center n.a. A.I. Burnazyan
🇷🇺Moscow, Russian Federation
Instituto di Ematologia ed Oncologia Medica
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Italy
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
🇫🇷Rouen, France
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
James Cancer Hospital / Ohio State University
🇺🇸Columbus, Ohio, United States
Temple Bone Marrow Transplant Program
🇺🇸Philadelphia, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380
🇺🇸Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Oregon Health and Science University / Center for Hematologic Malignancies
🇺🇸Portland, Oregon, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie
🇨🇿Praha, Czechia
Vseobecni fakultni nemocnice v Prahe-I. interni klinika
🇨🇿Praha, Czechia
CHU Bordeaux Hopital Haut-Levaque
🇫🇷Pessac, France
CHU Nantes - Hopital Hotel Dieu Service Hematologie
🇫🇷Nantes, France
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
🇭🇺Budapest, Hungary
Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
🇵🇱Lublin, Poland
Gorodskaya bol'nica #31
🇷🇺St. Petersburg, Russian Federation
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High
🇷🇺St. Petersburg, Russian Federation
Sverdlovskaja oblastnaja klinicheskaja bol'nica #1
🇷🇺Yekaterinburg, Russian Federation
Centro Oncologico MD Anderson
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Paul
🇪🇸Barcelona, Spain
Hospital Universitaro de Salamanca
🇪🇸Salamanca, Spain
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Complejo Hospitalano de Navarra Servicio Hematologia
🇪🇸Pamplona, Navarra, Spain
Hospital Clinic i Provincial Servicio Hematologia
🇪🇸Barcelona, Spain
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Guy's Hospital Haematology Department, 4th Floor Southwark Wing
🇬🇧London, United Kingdom
St James University Hospital
🇬🇧Leeds, United Kingdom