A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
NCT ID: NCT01712490
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1334 participants
INTERVENTIONAL
2012-11-09
2026-01-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A + AVD
A+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.
brentuximab vedotin
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
doxorubicin
Doxorubicin: 25 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
dacarbazine
Dacarbazine (DTIC): 375 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
ABVD
ABVD 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.
doxorubicin
Doxorubicin: 25 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
bleomycin
Bleomycin: 10 units/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
dacarbazine
Dacarbazine (DTIC): 375 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Interventions
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brentuximab vedotin
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
doxorubicin
Doxorubicin: 25 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
bleomycin
Bleomycin: 10 units/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
dacarbazine
Dacarbazine (DTIC): 375 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2.
4. Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
Exclusion Criteria
2. Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
3. Sensory or motor peripheral neuropathy.
4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
5. Known human immunodeficiency virus (HIV) positive.
6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Gilbert, Arizona, United States
Tucson, Arizona, United States
Burbank, California, United States
Duarte, California, United States
Fresno, California, United States
Fullerton, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Santa Barbara, California, United States
Santa Monica, California, United States
Stanford, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lonetree, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Lawrenceville, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Niles, Illinois, United States
Zion, Illinois, United States
Fort Wayne, Indiana, United States
Goshen, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Fairway, Kansas, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Basking Ridge, New Jersey, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Commack, New York, United States
New York, New York, United States
Rochester, New York, United States
Rockville Centre, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Kennewick, Washington, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Yakima, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Kingswood, New South Wales, Australia
St Leonards, New South Wales, Australia
Westmead, New South Wales, Australia
South Brisbane, Queensland, Australia
Bedford Park, South Australia, Australia
Hobart, Tasmania, Australia
East Melbourne, Victoria, Australia
Geelong, Victoria, Australia
Heidelberg, Victoria, Australia
Parkville, Victoria, Australia
Perth, Western Australia, Australia
Antwerp, , Belgium
Bruges, , Belgium
Ghent, , Belgium
Salvador, Estado de Bahia, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santo André, São Paulo, Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Hradec Králové, , Czechia
Prague, , Czechia
Aalborg, , Denmark
Aarhus C, , Denmark
Copenhagen, , Denmark
Odense C, , Denmark
Roskilde, , Denmark
Argenteuil, Cedex, France
La Tronche, , France
Limoges, , France
Paris, , France
Lai Chi Kok, Kowloon, Hong Kong
Hong Kong, , Hong Kong
Tuenmen, , Hong Kong
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Modena, Emilia-Romagna, Italy
Rome, Lazio, Italy
Alessandria, , Italy
Bologna, , Italy
Cagliari, , Italy
Cuneo, , Italy
Genova, , Italy
Milan, , Italy
Napoli, , Italy
Rionero in Volture, , Italy
Rome, , Italy
Rozzano, , Italy
Torrette Di Ancona, , Italy
Higashiku, Fukuoka, Japan
Minamiku, Fukuoka-city, Japan
Minamiku, Hiroshima-city, Japan
Shōwamachi, Maebashi-city, Japan
Chikusa-ku, Nagoya, Japan
Suita, Osaka, Japan
Aoba-ku, Sendai-city, Japan
Chūōku, , Japan
Isehara-shi, , Japan
Kōtoku, , Japan
Bergen, , Norway
Oslo, , Norway
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
L0dz, , Poland
Olsztyn, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Ufa, Bashkortostan Republic, Russia
Saint Petersburg, Poselok Pesochny, Russia
Kazan', Republic Tatrstan, Russia
Moscow, , Russia
Moskva, , Russia
Saint Petersburg, , Russia
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
eManzimtoti, KwaZulu-Natal, South Africa
Bloemfontein, , South Africa
Cape Town, , South Africa
Goyang-si, Gyeonggi-do, South Korea
Hwasun-gun, Jeollanam-do, South Korea
Seocho-gu, Seoul, South Korea
Busan, , South Korea
Daegu, , South Korea
Incheon, , South Korea
Jeonju, , South Korea
Seoul, , South Korea
Badalona, , Spain
Barcelona, , Spain
Marbella, , Spain
Pamplona, , Spain
Salamanca, , Spain
Santiago de Compostela, , Spain
Valencia, , Spain
Changhua, , Taiwan
Chiayi County 613, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Truro, Cornwall, United Kingdom
Aberdeen, Scotland, United Kingdom
Glasgow, Scotland, United Kingdom
Sutton, Surrey, United Kingdom
Cardiff, Wales, United Kingdom
Birmingham, , United Kingdom
Canterbury, , United Kingdom
Exeter, , United Kingdom
Inverness, , United Kingdom
Leicester, , United Kingdom
Lincoln, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Norfolk, , United Kingdom
Northwood, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
Romford, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C25003
Identifier Type: -
Identifier Source: org_study_id
2011-005450-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1161-4937
Identifier Type: REGISTRY
Identifier Source: secondary_id
12/LO/1950
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-142491
Identifier Type: REGISTRY
Identifier Source: secondary_id
REec-2013-0114
Identifier Type: REGISTRY
Identifier Source: secondary_id
1025002760
Identifier Type: REGISTRY
Identifier Source: secondary_id
C25003CTID
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506419-16-00
Identifier Type: CTIS
Identifier Source: secondary_id