A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
9 other identifiers
interventional
1,334
21 countries
215
Brief Summary
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin \[Adriamycin\], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin \[Adriamycin\],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2012
Longer than P75 for phase_3
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedStudy Start
First participant enrolled
November 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2017
CompletedResults Posted
Study results publicly available
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2026
CompletedFebruary 27, 2026
February 1, 2026
4.4 years
October 19, 2012
April 18, 2018
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.
Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)
Secondary Outcomes (18)
Overall Survival (OS)
Baseline until death (approximately up to 4 years)
Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF
Baseline up to end of randomized regimen (approximately 1 year)
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Number of Participants With Abnormal Clinical Laboratory Values
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Event-free Survival (EFS) Per IRF
Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
- +13 more secondary outcomes
Study Arms (2)
A + AVD
EXPERIMENTALA+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.
ABVD
ACTIVE COMPARATORABVD consists of doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.
Interventions
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
Doxorubicin: 25 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Dacarbazine (DTIC): 375 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Treatment-naïve participants with Ann Arbor Stage III or IV HL.
- Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2.
- Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
You may not qualify if:
- Nodular lymphocyte predominant Hodgkin lymphoma.
- Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
- Sensory or motor peripheral neuropathy.
- Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
- Known human immunodeficiency virus (HIV) positive.
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Seagen Inc.collaborator
Study Sites (215)
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Birmingham, Alabama, United States
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Gilbert, Arizona, United States
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Tucson, Arizona, United States
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Burbank, California, United States
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Duarte, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Luis Obispo, California, United States
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Santa Barbara, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Lonetree, Colorado, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Lawrenceville, Georgia, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Niles, Illinois, United States
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Zion, Illinois, United States
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Fort Wayne, Indiana, United States
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Goshen, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Fairway, Kansas, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Basking Ridge, New Jersey, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Commack, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Rockville Centre, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Vancouver, Washington, United States
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Yakima, Washington, United States
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Morgantown, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Kingswood, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Westmead, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Bedford Park, South Australia, Australia
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Hobart, Tasmania, Australia
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East Melbourne, Victoria, Australia
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Geelong, Victoria, Australia
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Heidelberg, Victoria, Australia
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Parkville, Victoria, Australia
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Perth, Western Australia, Australia
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Antwerp, Belgium
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Bruges, Belgium
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Ghent, Belgium
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Salvador, Estado de Bahia, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Santo André, São Paulo, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Hradec Králové, Czechia
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Prague, Czechia
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Aalborg, Denmark
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Aarhus C, Denmark
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Copenhagen, Denmark
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Odense C, Denmark
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Roskilde, Denmark
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Argenteuil, Cedex, France
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La Tronche, France
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Limoges, France
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Paris, France
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Lai Chi Kok, Kowloon, Hong Kong
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Hong Kong, Hong Kong
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Tuenmen, Hong Kong
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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Modena, Emilia-Romagna, Italy
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Rome, Lazio, Italy
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Alessandria, Italy
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Bologna, Italy
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Cagliari, Italy
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Cuneo, Italy
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Genova, Italy
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Milan, Italy
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Naples, Italy
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Rionero in Volture, Italy
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Rome, Italy
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Rozzano, Italy
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Torrette Di Ancona, Italy
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Higashiku, Fukuoka, Japan
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Minamiku, Fukuoka-city, Japan
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Minamiku, Hiroshima-city, Japan
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Shōwamachi, Maebashi-city, Japan
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Chikusa-ku, Nagoya, Japan
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Suita, Osaka, Japan
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Aoba-ku, Sendai-city, Japan
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Chūōku, Japan
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Isehara-shi, Japan
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Kōtoku, Japan
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Bergen, Norway
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Oslo, Norway
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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L0dz, Poland
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Olsztyn, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Ufa, Bashkortostan Republic, Russia
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Saint Petersburg, Poselok Pesochny, Russia
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Kazan', Republic Tatrstan, Russia
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Moscow, Russia
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Moskva, Russia
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Saint Petersburg, Russia
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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eManzimtoti, KwaZulu-Natal, South Africa
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Bloemfontein, South Africa
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Cape Town, South Africa
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Goyang-si, Gyeonggi-do, South Korea
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Hwasun-gun, Jeollanam-do, South Korea
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Seocho-gu, Seoul, South Korea
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Busan, South Korea
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Daegu, South Korea
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Incheon, South Korea
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Jeonju, South Korea
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Seoul, South Korea
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Badalona, Spain
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Barcelona, Spain
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Marbella, Spain
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Pamplona, Spain
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Salamanca, Spain
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Santiago de Compostela, Spain
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Valencia, Spain
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Changhua, Taiwan
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Chiayi County 613, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Truro, Cornwall, United Kingdom
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Aberdeen, Scotland, United Kingdom
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Glasgow, Scotland, United Kingdom
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Sutton, Surrey, United Kingdom
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Cardiff, Wales, United Kingdom
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Birmingham, United Kingdom
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Canterbury, United Kingdom
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Exeter, United Kingdom
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Inverness, United Kingdom
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Leicester, United Kingdom
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Lincoln, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Norfolk, United Kingdom
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Northwood, United Kingdom
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Nottingham, United Kingdom
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Oxford, United Kingdom
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Romford, United Kingdom
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Southampton, United Kingdom
Related Publications (9)
Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
PMID: 40135712DERIVEDCrosswell HE, LaCasce AS, Bartlett NL, Straus DJ, Savage KJ, Zinzani PL, Collins GP, Fanale M, Fenton K, Dong C, Miao H, Grigg AP. Brentuximab vedotin with chemotherapy in adolescents and young adults with stage III or IV classical Hodgkin lymphoma in ECHELON-1. Haematologica. 2024 Mar 1;109(3):982-987. doi: 10.3324/haematol.2023.283303. No abstract available.
PMID: 37794803DERIVEDAnsell SM, Radford J, Connors JM, Dlugosz-Danecka M, Kim WS, Gallamini A, Ramchandren R, Friedberg JW, Advani R, Hutchings M, Evens AM, Smolewski P, Savage KJ, Bartlett NL, Eom HS, Abramson JS, Dong C, Campana F, Fenton K, Puhlmann M, Straus DJ; ECHELON-1 Study Group. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2022 Jul 28;387(4):310-320. doi: 10.1056/NEJMoa2206125. Epub 2022 Jul 13.
PMID: 35830649DERIVEDEvens AM, Connors JM, Younes A, Ansell SM, Kim WS, Radford J, Feldman T, Tuscano J, Savage KJ, Oki Y, Grigg A, Pocock C, Dlugosz-Danecka M, Fenton K, Forero-Torres A, Liu R, Jolin H, Gautam A, Gallamini A. Older patients (aged >/=60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study. Haematologica. 2022 May 1;107(5):1086-1094. doi: 10.3324/haematol.2021.278438.
PMID: 34162178DERIVEDStraus DJ, Dlugosz-Danecka M, Connors JM, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Munoz J, Lee HJ, Kim WS, Advani R, Ansell SM, Younes A, Gallamini A, Liu R, Little M, Fenton K, Fanale M, Radford J. Brentuximab vedotin with chemotherapy for stage III or IV classical Hodgkin lymphoma (ECHELON-1): 5-year update of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e410-e421. doi: 10.1016/S2352-3026(21)00102-2.
PMID: 34048680DERIVEDStraus DJ, Dlugosz-Danecka M, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Connors JM, Radford J, Munoz J, Kim WS, Advani R, Ansell SM, Younes A, Miao H, Liu R, Fenton K, Forero-Torres A, Gallamini A. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020 Mar 5;135(10):735-742. doi: 10.1182/blood.2019003127.
PMID: 31945149DERIVEDRamchandren R, Advani RH, Ansell SM, Bartlett NL, Chen R, Connors JM, Feldman T, Forero-Torres A, Friedberg JW, Gopal AK, Gordon LI, Kuruvilla J, Savage KJ, Younes A, Engley G, Manley TJ, Fenton K, Straus DJ. Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma. Clin Cancer Res. 2019 Mar 15;25(6):1718-1726. doi: 10.1158/1078-0432.CCR-18-2435. Epub 2019 Jan 7.
PMID: 30617130DERIVEDConnors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J; ECHELON-1 Study Group. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2018 Jan 25;378(4):331-344. doi: 10.1056/NEJMoa1708984. Epub 2017 Dec 10.
PMID: 29224502DERIVEDYounes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.
PMID: 24239220DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 23, 2012
Study Start
November 9, 2012
Primary Completion
April 20, 2017
Study Completion
February 2, 2026
Last Updated
February 27, 2026
Results First Posted
November 27, 2018
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.