Clinical trial NCT01777152: 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
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anaplastic Large-Cell Lymphoma
Non-Hodgkin Lymphoma
T-Cell Lymphoma
Keywords: Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Lymphoma
Monomethyl auristatin E
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2013-01-28
Enrollment: 452
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 double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
* 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:

* History of another primary invasive malignancy that has not been in remission for at least 3 years
* 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

Primary outcomes:
measure: Progression-free Survival Per Independent Review Facility (IRF)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
timeFrame: Up to 60 months
measure: Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
timeFrame: Up to 8.34 months
measure: Overall Survival (OS)
timeFrame: Up to 90 months
measure: Objective Response Rate (ORR) Per IRF at End of Treatment
timeFrame: Up to 8.34 months
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 8.28 months
measure: Incidence of Laboratory Abnormalities
timeFrame: Up to 8.28 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Gainesville
country: United States
facility: Shands Cancer Center / University of Florida
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center / University of Iowa
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center - Basking Ridge
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein Cancer Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center - Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center / University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Jewish Hospital, The
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic, The
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Clinic Oncology
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center / Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute/Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Bentleigh East
country: Australia
facility: Moorabbin Hospital
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
city: Chermside
country: Australia
facility: Icon Cancer Care South Brisbane
city: Chermside
country: Australia
facility: Icon Cancer Care Southport
city: Chermside
country: Australia
facility: Icon Cancer Care Wesley
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
city: Fitzroy
country: Australia
facility: St Vincent's Public Hospital Sydney - Fitzroy
city: Footscray
country: Australia
facility: Western Hospital
city: Heidelberg
country: Australia
facility: Austin Health
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
city: Montreal
country: Canada
facility: McGill University Department of Oncology / McGill University Health Centre
city: Montreal
country: Canada
facility: Jewish General Hospital
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
city: Ostrava - Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Aarhus C.
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigs Hospiltalet
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: La Roche-sur-Yon Cedex 9
country: France
facility: CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille cedex
country: France
facility: CHRU de Lille
city: Limoges Cedex
country: France
facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
city: Nantes cedex 1
country: France
facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu
city: Paris Cedex 10
country: France
facility: Hopital Saint-Louis / Service d'Hematologie
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpétrière
city: Pessac
country: France
facility: Groupe Hospitalier du Haut Leveque
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest GmbH
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Klinik für Innere Medizin II, Friedrich-Schiller-Universität
city: Köln
country: Germany
facility: Universitatsklinikum Koln
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität München
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Beer Sheva
country: Israel
facility: Soroka Medical Center, Dept. of Oncology
city: Haifa
country: Israel
facility: Rambam Health Corp.
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Instituto di Ematologia ed Oncologia Medica
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Catania
country: Italy
facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale Niguarda Ca' Granda
city: Pavia
country: Italy
facility: IRCSS Policlinico San Matteo
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
city: Roma
country: Italy
facility: Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas-Humanitas Cancer Center
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
city: Chorzów
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Warsaw
country: Poland
facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Paul
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català D'oncologia
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Salamanca
country: Spain
facility: Hospital Universitaro de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Taoyuan
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Saint George's Hospital NHS Trust
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Seagen Inc.
name: Thomas Manley, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.