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 (ECHELON-2)

November 1, 2021 updated by: Seagen Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

452

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Bentleigh East, Australia, 3165
        • Moorabbin Hospital
      • Chermside, Australia, 4032
        • Icon Cancer Care Chermside
      • Chermside, Australia, 4032
        • Icon Cancer Care South Brisbane
      • Chermside, Australia, 4032
        • Icon Cancer Care Southport
      • Chermside, Australia, 4032
        • Icon Cancer Care Wesley
      • Clayton, Australia, 3168
        • Monash Medical Centre
      • Concord, Australia, 2139
        • Concord Repatriation General Hospital
      • Darlinghurst, Australia, 2010
        • St. Vincent's Hospital Sydney
      • Fitzroy, Australia, 3065
        • St Vincent's Public Hospital Sydney - Fitzroy
      • Footscray, Australia, 3011
        • Western Hospital
      • Heidelberg, Australia, 3084
        • Austin Health
      • Waratah, Australia, 2298
        • Calvary Mater Newcastle
  • Canada
      • Montreal, Canada, H3H 2R9
        • McGill University Department of Oncology / McGill University Health Centre
      • Montreal, Canada, H3T 1E2
        • Jewish General Hospital
      • Toronto, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Vancouver, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Centre
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultní nemocnice Brno
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
      • Ostrava - Poruba, Czechia, 708 52
        • Fakultni nemocnice Ostrava
      • Praha 10, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
  • Denmark
      • Aarhus C., Denmark, 8000
        • Aarhus University Hospital
      • Copenhagen, Denmark, DK 2100
        • Rigs Hospiltalet
      • Odense C, Denmark, 5000
        • Odense University Hospital
  • France
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • La Roche-sur-Yon Cedex 9, France, 85925
        • CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire de Grenoble
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Lille cedex, France, 59037
        • CHRU de Lille
      • Limoges Cedex, France, 87042
        • Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
      • Nantes cedex 1, France, 44093
        • Centre Hospitalier Universitaire Nantes-Hotel Dieu
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
      • Paris Cedex 10, France, 75475
        • Hopital Saint-Louis / Service d'Hematologie
      • Pessac, France, 33604
        • Groupe Hospitalier Du Haut Leveque
      • Pierre Bénite Cedex, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers Cedex, France, 86021
        • Centre Hospitalier Universitaire de Poitiers
      • Rennes Cedex 9, France, 35033
        • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
  • Germany
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin
      • Chemnitz, Germany, 09113
        • Klinikum Chemnitz gGmbH
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Frankfurt am Main, Germany, 60488
        • Krankenhaus Nordwest GmbH
      • Göttingen, Germany, 37075
        • Georg-August-Universität Göttingen
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Homburg/Saar, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Jena, Germany, 07747
        • Klinik für Innere Medizin II, Friedrich-Schiller-Universität
      • Köln, Germany, 50937
        • Universitätsklinikum Köln
      • München, Germany, 81377
        • Klinikum der Ludwig-Maximilians-Universität München
      • Nürnberg, Germany, 90419
        • Klinikum Nürnberg
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem
      • Kaposvár, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Szombathely, Hungary, 9700
        • Markusovszky Egyetemi Oktatokorhaz
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka Medical Center, Dept. of Oncology
      • Haifa, Israel, 31096
        • Rambam Health Corp.
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Petach Tikva, Israel, 49414
        • Rabin Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bologna, Italy, 40138
        • Instituto di Ematologia ed Oncologia Medica
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Catania, Italy, 95124
        • Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria San Martino
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20162
        • Ospedale Niguarda Ca' Granda
      • Pavia, Italy, 27100
        • IRCSS Policlinico San Matteo
      • Pesaro, Italy, 61100
        • Azienda Ospedaliera Ospedali Riuniti Marche Nord
      • Roma, Italy, 00161
        • Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas-Humanitas Cancer Center
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata di Verona
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center
      • Hwasun, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 137-701
        • Seoul Saint Mary's Hospital
      • Seoul, Korea, Republic of, 138-876
        • Asan Medical Center
  • Poland
      • Brzozow, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza
      • Chorzów, Poland, 41-500
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne s.c.
      • Warsaw, Poland, 02-781
        • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
  • Romania
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
      • Bucuresti, Romania, 030171
        • Spitalul Clinic Coltea
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
      • Targu Mures, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
  • Spain
      • Barcelona, Spain, 08028
        • Institut Universitari Dexeus
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Paul
      • L'Hospitalet de Llobregat, Spain, 08907
        • Institut Catala d'Oncologia
      • León, Spain, 24071
        • Hospital de Leon
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Majadahonda, Spain, 28222
        • Hospital Puerta de Hierro Majadahonda
      • Salamanca, Spain, 37007
        • Hospital Universitaro de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital - Kaohsiung
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng-Kung University Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital - Taoyuan
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust
      • London, United Kingdom, SW17 0RE
        • Saint George's Hospital NHS Trust
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Nottingham, United Kingdom, NG5 1PD
        • Nottingham University Hospitals NHS Trust
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Cancer Center / University of Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center / Loyola University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center / University of Iowa
    • Kansas
      • Westwood, Kansas, United States, United States
        • University of Kansas Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center - Basking Ridge
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Albert Einstein Cancer Center
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center - Commack
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10022
        • Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center / University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Jewish Hospital, The
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, The
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Clinic Oncology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, United States
        • Thomas Jefferson University
    • Tennessee
      • Nashville, Tennessee, United States, 30384
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Charles A. Sammons Cancer Center / Baylor University Medical Center
      • Houston, Texas, United States, 77030-4095
        • MD Anderson Cancer Center / University of Texas
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance / University of Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute/Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
Drug: vincristine
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Experimental: A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
Other Names:
  • Adcetris; SGN-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival Per Independent Review Facility (IRF)
Time Frame: Up to 60 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
Time Frame: Up to 60 months
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
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
Time Frame: Up to 8.34 months
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.
Up to 8.34 months
Overall Survival (OS)
Time Frame: Up to 90 months
The time from randomization to death due to any cause.
Up to 90 months
Objective Response Rate (ORR) Per IRF at End of Treatment
Time Frame: Up to 8.34 months
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.
Up to 8.34 months
Incidence of Adverse Events (AEs)
Time Frame: Up to 8.28 months
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Up to 8.28 months
Incidence of Laboratory Abnormalities
Time Frame: Up to 8.28 months
Number of participants who experienced a Grade 3 or higher laboratory toxicity.
Up to 8.28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Director: Thomas Manley, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2013

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

October 2, 2020

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-014
  • 2012-002751-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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