Clinical trial NCT01100502: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Disease, Hodgkin
Keywords: Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Drug Therapy
Hematologic Diseases
Immunotherapy
Lymphoma
Monomethylauristatin E
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2010-04-09
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Progression-free Survival by Independent Review
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 10 years
measure: Incidence of Adverse Events or Laboratory Abnormalities
timeFrame: Up to 12 months
measure: Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Section of Hematology/Oncology Lymphoma Program
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic, The
state: Ohio
city: Columbus
country: United States
facility: James Cancer Hospital / Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University / Center for Hematologic Malignancies
state: Oregon
city: Philadelphia
country: United States
facility: Temple Bone Marrow Transplant Program
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Saint Francis Hospital
state: South Carolina
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Sofia
country: Bulgaria
facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
city: Sofia
country: Bulgaria
facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie
city: Praha
country: Czechia
facility: Vseobecni fakultni nemocnice v Prahe-I. interni klinika
city: Nantes
country: France
facility: CHU Nantes - Hopital Hotel Dieu Service Hematologie
city: Paris
country: France
facility: Service des Maladies du Sang / Hospital Saint Louis
city: Pessac
country: France
facility: CHU Bordeaux Hopital Haut-Levaque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
city: Koeln
country: Germany
facility: University Hospital of Cologne
city: Budapest
country: Hungary
facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
city: Pecs
country: Hungary
facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
city: Bologna
country: Italy
facility: Instituto di Ematologia ed Oncologia Medica
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
city: Gdansk
country: Poland
facility: Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
city: Gliwice
country: Poland
facility: Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Lublin
country: Poland
facility: Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
city: Warsaw
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warsaw
country: Poland
facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii
city: Warsaw
country: Poland
facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
state: Judetul Mures
city: Timisoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie
state: Judetul Timis
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
city: Moscow
country: Russian Federation
facility: Burdenko Central Military Clinical Hospital
city: Moscow
country: Russian Federation
facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
city: Moscow
country: Russian Federation
facility: Federal Medical Biophysical Center n.a. A.I. Burnazyan
city: Moscow
country: Russian Federation
facility: Gematologicheskj nauchnyj centr RAMN
city: Novosibirsk
country: Russian Federation
facility: Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii
city: Petrozavodsk
country: Russian Federation
facility: Respublikanskaja bol'nica im. V.A. Baranova
city: St. Petersburg
country: Russian Federation
facility: Leningradskaja oblastnaja klinicheskaja bol'nica
city: St. Petersburg
country: Russian Federation
facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University
city: St. Petersburg
country: Russian Federation
facility: Gorodskaya bol'nica #31
city: St. Petersburg
country: Russian Federation
facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovskaja oblastnaja klinicheskaja bol'nica #1
city: Belgrad
country: Serbia
facility: Klinicki centar Srbije, Klinika za hematologiju
city: Belgrad
country: Serbia
facility: Vojnomedicinska akademija, Klinika za hematologiju
city: Novi Sad
country: Serbia
facility: Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju
city: Pamplona
country: Spain
facility: Complejo Hospitalano de Navarra Servicio Hematologia
state: Navarra
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Paul
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial Servicio Hematologia
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson
city: Salamanca
country: Spain
facility: Hospital Universitaro de Salamanca
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Guy's Hospital Haematology Department, 4th Floor Southwark Wing
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
Study officials:
affiliation: Seagen Inc.
name: Julie Lisano, PharmD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.