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Anaplastic Large-Cell LymphomaPhase 3ECHELON-2NCT01777152

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

A Phase 3 study testing brentuximab vedotin, doxorubicin and prednisone in people with Anaplastic Large-Cell Lymphoma and Non-Hodgkin Lymphoma, run by Seagen Inc. at 144 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
brentuximab vedotin, doxorubicin and prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
144 sitesin 16 countries
Study dates
31 Jan 2013to 2 Oct 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

144 sites in 16 countries.

144 sites in 16 countries

United States32 sites

  • Memorial Sloan Kettering Cancer Center - Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22908

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Jewish Hospital, The

    Cincinnati, Ohio, 45236

  • Cleveland Clinic, The

    Cleveland, Ohio, 44195

  • Memorial Sloan Kettering Cancer Center - Commack

    Commack, New York, 11725

  • Charles A. Sammons Cancer Center / Baylor University Medical Center

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • Shands Cancer Center / University of Florida

    Gainesville, Florida, 32610

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • Holden Comprehensive Cancer Center / University of Iowa

    Iowa City, Iowa, 52242

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 30384

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10022

  • Weill Cornell Medical College

    New York, New York, 10065

  • Mercy Clinic Oncology

    Oklahoma City, Oklahoma, 73120

  • Orlando Health, Inc.

    Orlando, Florida, 32806

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

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

    Rochester, New York, 14642

  • Benaroya Research Institute/Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington, 98109-1023

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Cancer Center

    Stanford, California, 94305

  • Albert Einstein Cancer Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Kansas Cancer Center

    Westwood, Kansas, United States

Other trials in United States

France14 sites

  • Hôpital Henri Mondor

    Créteil, 94010

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

    La Roche-sur-Yon, 85925

  • Centre Hospitalier Universitaire de Grenoble

    La Tronche, 38700

  • Clinique Victor Hugo

    Le Mans, 72000

  • CHRU de Lille

    Lille, 59037

  • Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

    Limoges, 87042

  • Centre Hospitalier Universitaire Nantes-Hotel Dieu

    Nantes, 44093

  • Groupe Hospitalier Pitié-Salpétrière

    Paris, 75013

  • Hopital Saint-Louis / Service d'Hematologie

    Paris, 75475

  • Groupe Hospitalier du Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

    Rouen, 76038

Other trials in France

Italy14 sites

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

    Alessandria, 15121

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Instituto di Ematologia ed Oncologia Medica

    Bologna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

    Catania, 95124

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale Niguarda Ca' Granda

    Milan, 20162

  • IRCSS Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, 61100

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

    Roma, 00161

  • Istituto Clinico Humanitas-Humanitas Cancer Center

    Rozzano, 20089

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37134

Other trials in Italy

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Moorabbin Hospital

    Bentleigh East, 3165

  • Icon Cancer Care Chermside

    Chermside, 4032

  • Icon Cancer Care South Brisbane

    Chermside, 4032

  • Icon Cancer Care Southport

    Chermside, 4032

  • Icon Cancer Care Wesley

    Chermside, 4032

  • Monash Medical Centre

    Clayton, 3168

  • Concord Repatriation General Hospital

    Concord, 2139

  • St. Vincent's Hospital Sydney

    Darlinghurst, 2010

  • St Vincent's Public Hospital Sydney - Fitzroy

    Fitzroy, 3065

  • Western Hospital

    Footscray, 3011

  • Austin Health

    Heidelberg, 3084

  • Calvary Mater Newcastle

    Waratah, 2298

Other trials in Australia

Germany13 sites

  • Charite Universitatsmedizin Berlin

    Berlin, 10117

  • Charite Campus Benjamin Franklin

    Berlin, 12203

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Universitatsklinikum Koln

    Cologne, 50937

  • Universitatsklinikum Essen

    Essen, 45122

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, 60488

  • Georg-August-Universität Göttingen

    Göttingen, 37075

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66421

  • Klinik für Innere Medizin II, Friedrich-Schiller-Universität

    Jena, 07747

  • Klinikum der Ludwig-Maximilians-Universität München

    München, 81377

  • Klinikum Nürnberg

    Nuremberg, 90419

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Spain11 sites

  • Hospital de la Santa Creu i Sant Paul

    Barcelona, 08025

  • Institut Universitari Dexeus

    Barcelona, 08028

  • Institut Català D'oncologia

    L'Hospitalet de Llobregat, 08907

  • Hospital de León

    León, 24071

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Universitaro de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

South Korea8 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-763

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Seoul Saint Mary's Hospital

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-876

Other trials in South Korea

United Kingdom6 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW

  • Saint George's Hospital NHS Trust

    London, SW17 0RE

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PD

Other trials in United Kingdom

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

    Hradec Králové, 500 05

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Israel5 sites

  • Soroka Medical Center, Dept. of Oncology

    Beersheba, 84101

  • Rambam Health Corp.

    Haifa, 31096

  • Hadassah Medical Center

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49414

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Canada4 sites

  • McGill University Department of Oncology / McGill University Health Centre

    Montreal, H3H 2R9

  • Jewish General Hospital

    Montreal, H3T 1E2

  • Sunnybrook Health Sciences Centre

    Toronto, M4N 3M5

  • British Columbia Cancer Agency - Vancouver Centre

    Vancouver, V5Z 4E6

Other trials in Canada

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem

    Debrecen, 4032

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

Other trials in Hungary

Poland4 sites

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

    Brzozów, 36-200

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

    Chorzów, 41-500

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Romania4 sites

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

    Bucharest, 022328

  • Spitalul Clinic Coltea

    Bucharest, 030171

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

    Cluj-Napoca, 400015

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

    Târgu Mureş, 540136

Other trials in Romania

Taiwan4 sites

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 404

  • National Cheng-Kung University Hospital

    Tainan, 70403

  • Chang Gung Memorial Hospital - Taoyuan

    Taoyuan, 33305

Other trials in Taiwan

Denmark3 sites

  • Aarhus University Hospital

    Aarhus C, 8000

  • Rigs Hospiltalet

    Copenhagen, DK 2100

  • Odense University Hospital

    Odense C, 5000

Other trials in Denmark

About this study

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

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.

Being tested
brentuximab vedotin, doxorubicin, prednisone, vincristine, cyclophosphamide
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
Medical subject headings
Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Hematologic Diseases, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brentuximab vedotinDrug

    Also called Adcetris; SGN-35

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

  • doxorubicinDrug

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

  • prednisoneDrug

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

  • vincristineDrug

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

  • cyclophosphamideDrug

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

Study groups in NCT01777152
Study groupRoleWhat they receive
CHOPActive comparatorcyclophosphamide, doxorubicin, vincristine, and prednisone
Receives: Drug: doxorubicin; Drug: prednisone; Drug: vincristine; Drug: cyclophosphamide
A+CHPExperimentalbrentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Receives: Drug: brentuximab vedotin; Drug: doxorubicin; Drug: prednisone; Drug: cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 60 months

Secondary outcomes (6)

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

    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.

    Measured: Up to 60 months

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

    The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to 8.34 months

  3. Overall Survival (OS)

    The time from randomization to death due to any cause.

    Measured: Up to 90 months

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

    The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to 8.34 months

  5. Incidence of Adverse Events (AEs)

    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to 8.28 months

  6. Incidence of Laboratory Abnormalities

    Number of participants who experienced a Grade 3 or higher laboratory toxicity.

    Measured: Up to 8.28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2013 (estimated)
  2. Study start31 Jan 2013
  3. Primary completion15 Aug 2018
  4. Study completion2 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01777152
Sponsor's protocol ID
SGN35-014
Other IDs
2012-002751-42
Acronym
ECHELON-2
Status last verified
Nov 2021
First submitted
23 Jan 2013
Last updated
30 Nov 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 40829107

  • 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.

    PubMed 40750774

  • 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.

    PubMed 35470385

  • 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.

    PubMed 30522922

  • 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.

    PubMed 25135998

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing brentuximab vedotin, doxorubicin and prednisone in people with Anaplastic Large-Cell Lymphoma and Non-Hodgkin Lymphoma, run by Seagen Inc. at 144 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, France, Italy, Australia, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival Per Independent Review Facility (IRF) (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01777152, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

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