ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
NCT ID: NCT01777152
Last Updated: 2021-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
452 participants
INTERVENTIONAL
2013-01-31
2020-10-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
vincristine
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Interventions
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brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
vincristine
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion Criteria
* Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
* History of progressive multifocal leukoencephalopathy (PML)
* Cerebral/meningeal disease related to the underlying malignancy
18 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Manley, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
Shands Cancer Center / University of Florida
Gainesville, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Holden Comprehensive Cancer Center / University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester, New York, United States
Albert Einstein Cancer Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Jewish Hospital, The
Cincinnati, Ohio, United States
Cleveland Clinic, The
Cleveland, Ohio, United States
Mercy Clinic Oncology
Oklahoma City, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Benaroya Research Institute/Virginia Mason Medical Center
Seattle, Washington, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, , Australia
Moorabbin Hospital
Bentleigh East, , Australia
Icon Cancer Care Chermside
Chermside, , Australia
Icon Cancer Care South Brisbane
Chermside, , Australia
Icon Cancer Care Southport
Chermside, , Australia
Icon Cancer Care Wesley
Chermside, , Australia
Monash Medical Centre
Clayton, , Australia
Concord Repatriation General Hospital
Concord, , Australia
St. Vincent's Hospital Sydney
Darlinghurst, , Australia
St Vincent's Public Hospital Sydney - Fitzroy
Fitzroy, , Australia
Western Hospital
Footscray, , Australia
Austin Health
Heidelberg, , Australia
Calvary Mater Newcastle
Waratah, , Australia
McGill University Department of Oncology / McGill University Health Centre
Montreal, , Canada
Jewish General Hospital
Montreal, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
British Columbia Cancer Agency - Vancouver Centre
Vancouver, , Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Králové, , Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, , Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Aarhus University Hospital
Aarhus C, , Denmark
Rigs Hospiltalet
Copenhagen, , Denmark
Odense University Hospital
Odense C, , Denmark
Hôpital Henri Mondor
Créteil, , France
CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies
La Roche-sur-Yon, , France
Centre Hospitalier Universitaire de Grenoble
La Tronche, , France
Clinique Victor Hugo
Le Mans, , France
CHRU de Lille
Lille, , France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
Limoges, , France
Centre Hospitalier Universitaire Nantes-Hotel Dieu
Nantes, , France
Groupe Hospitalier Pitié-Salpétrière
Paris, , France
Hopital Saint-Louis / Service d'Hematologie
Paris, , France
Groupe Hospitalier du Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
Rennes, , France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, , France
Charite Universitatsmedizin Berlin
Berlin, , Germany
Charite Campus Benjamin Franklin
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Universitatsklinikum Essen
Essen, , Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, , Germany
Georg-August-Universität Göttingen
Göttingen, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, , Germany
Klinik für Innere Medizin II, Friedrich-Schiller-Universität
Jena, , Germany
Klinikum der Ludwig-Maximilians-Universität München
München, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , Hungary
Soroka Medical Center, Dept. of Oncology
Beersheba, , Israel
Rambam Health Corp.
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, , Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Instituto di Ematologia ed Oncologia Medica
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
Catania, , Italy
Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale Niguarda Ca' Granda
Milan, , Italy
IRCSS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, , Italy
Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
Roma, , Italy
Istituto Clinico Humanitas-Humanitas Cancer Center
Rozzano, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, , Italy
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów, , Poland
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
Bucharest, , Romania
Spitalul Clinic Coltea
Bucharest, , Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
Târgu Mureş, , Romania
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital de la Santa Creu i Sant Paul
Barcelona, , Spain
Institut Universitari Dexeus
Barcelona, , Spain
Institut Català D'oncologia
L'Hospitalet de Llobregat, , Spain
Hospital de León
León, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Universitaro de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng-Kung University Hospital
Tainan City, , Taiwan
Chang Gung Memorial Hospital - Taoyuan
Taoyuan District, , Taiwan
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Saint George's Hospital NHS Trust
London, , United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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References
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Domingo-Domenech E, Pro B, Illidge T, Horwitz S, Trumper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Kim WS, Feldman T, Choi I, Gritti G, Belada D, Shustov A, Illes A, Zinzani PL, Huttmann A, Trneny M, Le Gouill S, Jagadeesh D, Friedberg JW, Little M, Dong C, Fanale M, Fenton K, Savage KJ. Brentuximab vedotin plus chemotherapy for the treatment of front-line systemic anaplastic large cell lymphoma: subgroup analysis of the ECHELON-2 study at 5 years' follow-up. Blood Cancer J. 2025 Aug 1;15(1):129. doi: 10.1038/s41408-025-01329-2.
Savage KJ, Horwitz SM, Advani R, Christensen JH, Domingo-Domenech E, Rossi G, Morschhauser F, Alpdogan O, Suh C, Tobinai K, Shustov A, Trneny M, Yuen S, Zinzani PL, Trumper L, Ilidge T, O'Connor OA, Pro B, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Iyer S. Role of stem cell transplant in CD30+ PTCL following frontline brentuximab vedotin plus CHP or CHOP in ECHELON-2. Blood Adv. 2022 Oct 11;6(19):5550-5555. doi: 10.1182/bloodadvances.2020003971.
Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illes A, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Huttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trumper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi: 10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4.
Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-002751-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SGN35-014
Identifier Type: -
Identifier Source: org_study_id