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

NCT01777152 | Completed Phase 3 Results

• 2 other identifiers: SGN35-0142012-002751-42
• Study Type: interventional
• Target: 452
• Locations: 16 countries
• Sites: 144

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Per Independent Review Facility (IRF)

  The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

  Up to 60 months

Secondary Outcomes (6)

• Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)

  Up to 60 months

• Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)

  Up to 8.34 months

• Overall Survival (OS)

  Up to 90 months

• Objective Response Rate (ORR) Per IRF at End of Treatment

  Up to 8.34 months

• Incidence of Adverse Events (AEs)

  Up to 8.28 months

Study Arms (2)

CHOP

ACTIVE COMPARATOR

cyclophosphamide, doxorubicin, vincristine, and prednisone

Drug: doxorubicin; Drug: prednisone; Drug: vincristine; Drug: cyclophosphamide

A+CHP

EXPERIMENTAL

brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone

Drug: brentuximab vedotin; Drug: doxorubicin; Drug: prednisone; Drug: cyclophosphamide

Interventions

brentuximab vedotin DRUG

1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles

Also known as: Adcetris; SGN-35

A+CHP

doxorubicin DRUG

50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

A+CHP; CHOP

prednisone DRUG

100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles

A+CHP; CHOP

vincristine DRUG

1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles

CHOP

cyclophosphamide DRUG

750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

A+CHP; CHOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (144)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Shands Cancer Center / University of Florida

Gainesville, Florida, 32610, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Cardinal Bernardin Cancer Center / Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Holden Comprehensive Cancer Center / University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, United States, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center - Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10022, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

James P. Wilmot Cancer Center / University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Albert Einstein Cancer Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Jewish Hospital, The

Cincinnati, Ohio, 45236, United States

Location

Cleveland Clinic, The

Cleveland, Ohio, 44195, United States

Location

Mercy Clinic Oncology

Oklahoma City, Oklahoma, 73120, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 30384, United States

Location

Charles A. Sammons Cancer Center / Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4095, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Benaroya Research Institute/Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109-1023, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Moorabbin Hospital

Bentleigh East, 3165, Australia

Location

Icon Cancer Care Chermside

Chermside, 4032, Australia

Location

Icon Cancer Care South Brisbane

Chermside, 4032, Australia

Location

Icon Cancer Care Southport

Chermside, 4032, Australia

Location

Icon Cancer Care Wesley

Chermside, 4032, Australia

Location

Monash Medical Centre

Clayton, 3168, Australia

Location

Concord Repatriation General Hospital

Concord, 2139, Australia

Location

St. Vincent's Hospital Sydney

Darlinghurst, 2010, Australia

Location

St Vincent's Public Hospital Sydney - Fitzroy

Fitzroy, 3065, Australia

Location

Western Hospital

Footscray, 3011, Australia

Location

Austin Health

Heidelberg, 3084, Australia

Location

Calvary Mater Newcastle

Waratah, 2298, Australia

Location

McGill University Department of Oncology / McGill University Health Centre

Montreal, H3H 2R9, Canada

Location

Jewish General Hospital

Montreal, H3T 1E2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, M4N 3M5, Canada

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, V5Z 4E6, Canada

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

Hradec Králové, 500 05, Czechia

Location

Fakultni Nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

Location

Fakultni Nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Rigs Hospiltalet

Copenhagen, DK 2100, Denmark

Location

Odense University Hospital

Odense C, 5000, Denmark

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier Universitaire de Grenoble

La Tronche, 38700, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

CHRU de Lille

Lille, 59037, France

Location

Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

Limoges, 87042, France

Location

Centre Hospitalier Universitaire Nantes-Hotel Dieu

Nantes, 44093, France

Location

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

Hopital Saint-Louis / Service d'Hematologie

Paris, 75475, France

Location

Groupe Hospitalier du Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

Rouen, 76038, France

Location

Charite Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

Charite Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09113, Germany

Location

Universitatsklinikum Koln

Cologne, 50937, Germany

Location

Universitatsklinikum Essen

Essen, 45122, Germany

Location

Krankenhaus Nordwest GmbH

Frankfurt am Main, 60488, Germany

Location

Georg-August-Universität Göttingen

Göttingen, 37075, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

Location

Klinik für Innere Medizin II, Friedrich-Schiller-Universität

Jena, 07747, Germany

Location

Klinikum der Ludwig-Maximilians-Universität München

München, 81377, Germany

Location

Klinikum Nürnberg

Nuremberg, 90419, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700, Hungary

Location

Soroka Medical Center, Dept. of Oncology

Beersheba, 84101, Israel

Location

Rambam Health Corp.

Haifa, 31096, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Rabin Medical Center

Petah Tikva, 49414, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

Alessandria, 15121, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Instituto di Ematologia ed Oncologia Medica

Bologna, 40138, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

Catania, 95124, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

Location

IRCSS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, 61100, Italy

Location

Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

Roma, 00161, Italy

Location

Istituto Clinico Humanitas-Humanitas Cancer Center

Rozzano, 20089, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37134, Italy

Location

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

Brzozów, 36-200, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

Chorzów, 41-500, Poland

Location

Malopolskie Centrum Medyczne S.C.

Krakow, 30-510, Poland

Location

Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

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

Bucharest, 022328, Romania

Location

Spitalul Clinic Coltea

Bucharest, 030171, Romania

Location

Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

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

Târgu Mureş, 540136, Romania

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, 519-763, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Seoul Saint Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-876, South Korea

Location

Hospital de la Santa Creu i Sant Paul

Barcelona, 08025, Spain

Location

Institut Universitari Dexeus

Barcelona, 08028, Spain

Location

Institut Català D'oncologia

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital de León

León, 24071, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Hospital Universitaro de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, 70403, Taiwan

Location

Chang Gung Memorial Hospital - Taoyuan

Taoyuan District, 33305, Taiwan

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Saint George's Hospital NHS Trust

London, SW17 0RE, United Kingdom

Location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PD, United Kingdom

Location

Related Publications (5)

• Iyer S, Mehta-Shah N, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Alpdogan O, Feldman TA, Camus V, Gritti G, Zinzani PL, Belada D, Mayer J, Choi I, Cheong JW, Rustia E, Fenton K, Fanale M, Savage KJ, Horwitz SM. Association of PET4 response with outcomes of BV-CHP vs CHOP in the ECHELON-2 trial in CD30+ peripheral T-cell lymphoma. Blood Adv. 2025 Dec 9;9(23):5976-5987. doi: 10.1182/bloodadvances.2024015282.

  PMID: 40829107 DERIVED

• 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.

  PMID: 40750774 DERIVED

• 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.

  PMID: 35470385 DERIVED

• 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.

  PMID: 30522922 DERIVED

• 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.

  PMID: 25135998 DERIVED

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Hematologic Diseases; Lymphoma

Interventions

Brentuximab Vedotin; Doxorubicin; Prednisone; Vincristine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Seagen Inc.

medinfo@seagen.com

(855)473-2436

Study Officials

• Thomas Manley, MD

  Seagen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 28, 2013
• Study Start: January 31, 2013
• Primary Completion: August 15, 2018
• Study Completion: October 2, 2020
• Last Updated: November 30, 2021
• Results First Posted: July 30, 2019

Record last verified: 2021-11

Locations

DE (13); AU (13); TW (4); CA (4); GB (6); HU (4); PL (4); US (32); IL (5); ES (11); FR (14); RO (4); IT (14); KR (8); DK (3); CZ (5)