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AzTrials

Hodgkin LymphomaPhase 3NCT01712490

A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

A Phase 3 study testing brentuximab vedotin, doxorubicin and bleomycin in people with Hodgkin Lymphoma, run by Takeda at 215 sites in 21 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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
brentuximab vedotin, doxorubicin and bleomycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,334 participants
Where
215 sitesin 21 countries
Study dates
9 Nov 2012to 2 Feb 2026
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

  • 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.

Who cannot join

  • 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.
  • Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.

Trial locations and contacts

215 sites in 21 countries.

215 sites in 21 countries

United States83 sites

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Ann Arbor, Michigan

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Basking Ridge, New Jersey

  • Study site

    Bethesda, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Bismarck, North Dakota

  • Study site

    Boston, Massachusetts

  • Study site

    Burbank, California

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Commack, New York

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Duarte, California

  • Study site

    Eugene, Oregon

  • Study site

    Fairfax, Virginia

  • Study site

    Fairway, Kansas

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Wayne, Indiana

  • Study site

    Fresno, California

  • Study site

    Fullerton, California

  • Study site

    Gilbert, Arizona

  • Study site

    Goshen, Indiana

  • Study site

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Iowa City, Iowa

  • Study site

    Jacksonville, Florida

  • Study site

    Kennewick, Washington

  • Study site

    Knoxville, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lawrenceville, Georgia

  • Study site

    Lincoln, Nebraska

  • Study site

    Lonetree, Colorado

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Maywood, Illinois

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Morgantown, West Virginia

  • Study site

    Morristown, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Niles, Illinois

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Rockville Centre, New York

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Luis Obispo, California

  • Study site

    Santa Barbara, California

  • Study site

    Santa Monica, California

  • Study site

    Seattle, Washington

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    The Bronx, New York

  • Study site

    Tucson, Arizona

  • Study site

    Tyler, Texas

  • Study site

    Vancouver, Washington

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Yakima, Washington

  • Study site

    Zion, Illinois

Other trials in United States

United Kingdom20 sites

  • Study site

    Aberdeen, Scotland

  • Study site

    Birmingham

  • Study site

    Canterbury

  • Study site

    Cardiff, Wales

  • Study site

    Exeter

  • Study site

    Glasgow, Scotland

  • Study site

    Inverness

  • Study site

    Leicester

  • Study site

    Lincoln

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Norfolk

  • Study site

    Northwood

  • Study site

    Nottingham

  • Study site

    Oxford

  • Study site

    Romford

  • Study site

    Southampton

  • Study site

    Sutton, Surrey

  • Study site

    Truro, Cornwall

Other trials in United Kingdom

Italy13 sites

  • Study site

    Alessandria

  • Study site

    Bologna

  • Study site

    Cagliari

  • Study site

    Cuneo

  • Study site

    Genova

  • Study site

    Milan

  • Study site

    Modena, Emilia-Romagna

  • Study site

    Naples

  • Study site

    Rionero in Volture

  • Study site

    Rome, Lazio

  • Study site

    Rome

  • Study site

    Rozzano

  • Study site

    Torrette Di Ancona

Other trials in Italy

Australia11 sites

  • Study site

    Bedford Park, South Australia

  • Study site

    East Melbourne, Victoria

  • Study site

    Geelong, Victoria

  • Study site

    Heidelberg, Victoria

  • Study site

    Hobart, Tasmania

  • Study site

    Kingswood, New South Wales

  • Study site

    Parkville, Victoria

  • Study site

    Perth, Western Australia

  • Study site

    South Brisbane, Queensland

  • Study site

    St Leonards, New South Wales

  • Study site

    Westmead, New South Wales

Other trials in Australia

Japan10 sites

  • Study site

    Aoba-ku, Sendai-city

  • Study site

    Chikusa-ku, Nagoya

  • Study site

    Chūōku

  • Study site

    Higashiku, Fukuoka

  • Study site

    Isehara-shi

  • Study site

    Kōtoku

  • Study site

    Minamiku, Fukuoka-city

  • Study site

    Minamiku, Hiroshima-city

  • Study site

    Shōwamachi, Maebashi-city

  • Study site

    Suita, Osaka

Other trials in Japan

South Korea8 sites

  • Study site

    Busan

  • Study site

    Daegu

  • Study site

    Goyang-si, Gyeonggi-do

  • Study site

    Hwasun-gun, Jeollanam-do

  • Study site

    Incheon

  • Study site

    Jeonju

  • Study site

    Seocho-gu, Seoul

  • Study site

    Seoul

Other trials in South Korea

Canada7 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Montreal, Quebec

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Poland7 sites

  • Study site

    Gdansk

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    L0dz

  • Study site

    Olsztyn

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Spain7 sites

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    Marbella

  • Study site

    Pamplona

  • Study site

    Salamanca

  • Study site

    Santiago de Compostela

  • Study site

    Valencia

Other trials in Spain

Brazil6 sites

  • Study site

    Curitiba, Paraná

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Rio de Janeiro

  • Study site

    Salvador, Estado de Bahia

  • Study site

    Santo André, São Paulo

  • Study site

    São Paulo

Other trials in Brazil

Russia6 sites

  • Study site

    Kazan', Republic Tatrstan

  • Study site

    Moscow

  • Study site

    Moskva

  • Study site

    Saint Petersburg, Poselok Pesochny

  • Study site

    Saint Petersburg

  • Study site

    Ufa, Bashkortostan Republic

Other trials in Russia

Denmark5 sites

  • Study site

    Aalborg

  • Study site

    Aarhus C

  • Study site

    Copenhagen

  • Study site

    Odense C

  • Study site

    Roskilde

Other trials in Denmark

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Győr

  • Study site

    Pécs

  • Study site

    Szeged

Other trials in Hungary

South Africa5 sites

  • Study site

    Bloemfontein

  • Study site

    Cape Town

  • Study site

    eManzimtoti, KwaZulu-Natal

  • Study site

    Johannesburg, Gauteng

  • Study site

    Pretoria, Gauteng

Other trials in South Africa

Taiwan5 sites

  • Study site

    Changhua

  • Study site

    Chiayi County 613

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan County

Other trials in Taiwan

France4 sites

  • Study site

    Argenteuil, Cedex

  • Study site

    La Tronche

  • Study site

    Limoges

  • Study site

    Paris

Other trials in France

Belgium3 sites

  • Study site

    Antwerp

  • Study site

    Bruges

  • Study site

    Ghent

Other trials in Belgium

Hong Kong3 sites

  • Study site

    Hong Kong

  • Study site

    Lai Chi Kok, Kowloon

  • Study site

    Tuenmen

Other trials in Hong Kong

Turkey (Türkiye)3 sites

  • Study site

    Ankara

  • Study site

    Istanbul

  • Study site

    Samsun

Other trials in Turkey (Türkiye)

Czechia2 sites

  • Study site

    Hradec Králové

  • Study site

    Prague

Other trials in Czechia

Norway2 sites

  • Study site

    Bergen

  • Study site

    Oslo

Other trials in Norway

About this study

Official title: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

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)

Being tested
brentuximab vedotin, doxorubicin, bleomycin, vinblastine, dacarbazine
Keywords
Hodgkin Lymphoma, Hodgkins Lymphoma, Antibody, Monoclonal, Antibody-Drug Conjugate, Antigens, CD-30, Immunotherapy, Lymphoma, Lymphoma, Classical, ECHELON-1
Medical subject headings
Hodgkin Disease, 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

    Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.

  • doxorubicinDrug

    Also called Adriamycin

    Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.

  • bleomycinDrug

    Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.

  • vinblastineDrug

    Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle

  • dacarbazineDrug

    Also called DTIC

    Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.

Study groups in NCT01712490
Study groupRoleWhat they receive
A + AVDExperimentalA+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.
Receives: Drug: brentuximab vedotin; Drug: doxorubicin; Drug: vinblastine; Drug: dacarbazine
ABVDActive 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.
Receives: Drug: doxorubicin; Drug: bleomycin; Drug: vinblastine; Drug: dacarbazine

What is being measured

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

  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.

    Measured: 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)

  1. Overall Survival (OS)

    OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.

    Measured: Baseline until death (approximately up to 4 years)

  2. Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF

    CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.

    Measured: Baseline up to end of randomized regimen (approximately 1 year)

  3. Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

    Measured: Baseline up to 30 days after last dose of study drug (approximately 1 year)

  4. Number of Participants With Abnormal Clinical Laboratory Values

    Measured: Baseline up to 30 days after last dose of study drug (approximately 1 year)

  5. Event-free Survival (EFS) Per IRF

    EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir per IRF.

    Measured: Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)

  6. Disease-free Survival (DFS) Per IRF

    DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.

    Measured: From CR until PD or death (approximately up to 4 years)

  7. Overall Response Rate (ORR) Per IRF

    ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

    Measured: Baseline up to end of randomized regimen (approximately 1 year)

  8. Duration of Response (DOR) Per IRF

    DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

    Measured: From first documented response until PD (approximately 4 years)

  9. Duration of Complete Remission (DOCR) Per IRF

    DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.

    Measured: From first documentation of CR until PD (approximately 4 years)

  10. Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy

    CR was defined as disappearance of all evidence of disease as determined by an IRF.

    Measured: Baseline up to end of frontline therapy (approximately 4 years)

  11. Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy

    CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.

    Measured: Baseline up to end of frontline therapy (approximately 4 years)

  12. Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2

    PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (<=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.

    Measured: Cycle 2 Day 25

  13. A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)

    Measured: Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

  14. A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

    Measured: Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

  15. A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb

    Measured: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

  16. A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE

    Measured: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

  17. A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin

    The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.

    Measured: Baseline up to end of treatment (approximately 1 year)

  18. Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT

    EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by >=50% of previously involved sites from nadir.

    Measured: Baseline up to end of treatment (approximately 1 year)

Timeline

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

  1. First posted23 Oct 2012 (estimated)
  2. Study start9 Nov 2012
  3. Primary completion20 Apr 2017
  4. Study completion2 Feb 2026

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
None (open label)
Enrolment
1,334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01712490
Sponsor's protocol ID
C25003
Other IDs
2011-005450-60, U1111-1161-4937, 12/LO/1950, JapicCTI-142491, REec-2013-0114, 1025002760, C25003CTID, 2023-506419-16-00
Status last verified
Feb 2026
First submitted
19 Oct 2012
Last updated
27 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40135712

  • Crosswell 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.

    PubMed 37794803

  • Ansell 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.

    PubMed 35830649

  • Evens 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.

    PubMed 34162178

  • Straus 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.

    PubMed 34048680

  • Straus 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.

    PubMed 31945149

  • Ramchandren 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.

    PubMed 30617130

  • Connors 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.

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  • Younes 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.

    PubMed 24239220

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing brentuximab vedotin, doxorubicin and bleomycin in people with Hodgkin Lymphoma, run by Takeda at 215 sites in 21 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 4 inclusion and 7 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in United States, United Kingdom, Italy, Australia, Japan and 16 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 27 Nov 2018). 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?

Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) (time frame: Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)). 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 NCT01712490, which also lists 9 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 27 Feb 2026.

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