A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

Last updated: March 3, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphoma

White Cell Disorders

Hematologic Cancer

Treatment

bleomycin

vinblastine

brentuximab vedotin

Clinical Study ID

NCT01712490
C25003
1025002760
2011-005450-60
JapicCTI-142491
12/LO/1950
U1111-1161-4937
C25003CTID
2023-506419-16
REec-2013-0114
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.

  2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the currentWorld 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 theInternational Working Group Revised Criteria for Response Assessment for MalignantLymphoma.

Exclusion

Exclusion Criteria:

  1. Nodular lymphocyte predominant Hodgkin lymphoma.

  2. Cerebral/meningeal disease, including signs and symptoms of progressivemultifocalleukoencephalopathy (PML).

  3. Sensory or motor peripheral neuropathy.

  4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapywithin 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 Cinfection.

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

Study Design

Total Participants: 1334
Treatment Group(s): 5
Primary Treatment: bleomycin
Phase: 3
Study Start date:
November 09, 2012
Estimated Completion Date:
January 20, 2026

Connect with a study center

  • Kingswood, New South Wales
    Australia

    Site Not Available

  • St Leonards, New South Wales
    Australia

    Site Not Available

  • Westmead, New South Wales
    Australia

    Site Not Available

  • South Brisbane, Queensland
    Australia

    Site Not Available

  • Bedford Park, South Australia
    Australia

    Site Not Available

  • Hobart, Tasmania
    Australia

    Site Not Available

  • East Melbourne, Victoria
    Australia

    Site Not Available

  • Geelong, Victoria
    Australia

    Site Not Available

  • Heidelberg, Victoria
    Australia

    Site Not Available

  • Parkville, Victoria
    Australia

    Site Not Available

  • Perth, Western Australia
    Australia

    Site Not Available

  • Antwerpen,
    Belgium

    Site Not Available

  • Brugge,
    Belgium

    Site Not Available

  • Gent,
    Belgium

    Site Not Available

  • Salvador, Bahia
    Brazil

    Site Not Available

  • Curitiba, Parana
    Brazil

    Site Not Available

  • Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Santo Andre, Sao Paulo
    Brazil

    Site Not Available

  • Rio De Janeiro,
    Brazil

    Site Not Available

  • Sao paulo,
    Brazil

    Site Not Available

  • Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Winnipeg, Manitoba
    Canada

    Site Not Available

  • empty

    Winnipeg, Mb, Manitoba
    Canada

    Site Not Available

  • Halifax, Nova Scotia
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Site Not Available

  • Saskatoon, Saskatchewan
    Canada

    Site Not Available

  • Hradec Kralove,
    Czechia

    Site Not Available

  • Prague,
    Czechia

    Site Not Available

  • Praha 10,
    Czechia

    Site Not Available

  • Aalborg,
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 8000
    Denmark

    Site Not Available

  • Aarhus C,
    Denmark

    Site Not Available

  • Copenhagen,
    Denmark

    Site Not Available

  • empty

    Herlev,
    Denmark

    Site Not Available

  • empty

    Herlev Ringvej 75,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, 5000
    Denmark

    Site Not Available

  • Odense C,
    Denmark

    Site Not Available

  • Roskilde,
    Denmark

    Site Not Available

  • Argenteuil, Cedex
    France

    Site Not Available

  • empty

    Limoges cedex, Limoges
    France

    Site Not Available

  • Chu Grenoble

    Grenoble,
    France

    Site Not Available

  • La Tronche,
    France

    Site Not Available

  • Limoges,
    France

    Site Not Available

  • Paris,
    France

    Site Not Available

  • Lai Chi Kok, Kowloon
    Hong Kong

    Site Not Available

  • Hong Kong,
    Hong Kong

    Site Not Available

  • Tuen Mun,
    Hong Kong

    Site Not Available

  • empty

    Tuen Mun, New Territories,
    Hong Kong

    Site Not Available

  • Budapest,
    Hungary

    Site Not Available

  • Debrecen,
    Hungary

    Site Not Available

  • Gyor,
    Hungary

    Site Not Available

  • Pecs,
    Hungary

    Site Not Available

  • University of Pecs

    Pécs,
    Hungary

    Site Not Available

  • Szeged,
    Hungary

    Site Not Available

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    Szolnok,
    Hungary

    Site Not Available

  • Modena, Emilia-Romagna
    Italy

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  • Roma, 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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  • Milano,
    Italy

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  • Napoli,
    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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  • empty

    Rozzano Milano,
    Italy

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  • empty

    Rozzano, Milano,
    Italy

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  • Torrette Di Ancona,
    Italy

    Site Not Available

  • Higashi-ku, Fukuoka
    Japan

    Site Not Available

  • Minami-ku, Hiroshima-city
    Japan

    Site Not Available

  • Showamachi, Maebashi-city
    Japan

    Site Not Available

  • Chikusa-ku, Nagoya
    Japan

    Site Not Available

  • Suita, Osaka Prefecture
    Japan

    Site Not Available

  • Aoba-ku, Sendai-city
    Japan

    Site Not Available

  • Chuo-ku,
    Japan

    Site Not Available

  • Isehara-shi,
    Japan

    Site Not Available

  • Koto-ku,
    Japan

    Site Not Available

  • empty

    Seo-gu, Busan
    Korea, Republic of

    Site Not Available

  • Goyang, Gyeonggi
    Korea, Republic of

    Site Not Available

  • empty

    Hwasun-eup, Hwasun-gun
    Korea, Republic of

    Site Not Available

  • empty

    Namdong-gu, Incheon
    Korea, Republic of

    Site Not Available

  • Hwasun-gun, Jeollanam-do
    Korea, Republic of

    Site Not Available

  • Seocho-gu, Seoul
    Korea, Republic of

    Site Not Available

  • Busan,
    Korea, Republic of

    Site Not Available

  • Daegu,
    Korea, Republic of

    Site Not Available

  • Incheon,
    Korea, Republic of

    Site Not Available

  • Jeonju,
    Korea, Republic of

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

  • Bergen,
    Norway

    Site Not Available

  • Oslo,
    Norway

    Site Not Available

  • Gdansk,
    Poland

    Site Not Available

  • Katowice,
    Poland

    Site Not Available

  • Krakow,
    Poland

    Site Not Available

  • L0dz,
    Poland

    Site Not Available

  • empty

    Lodz,
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

    Lódz,
    Poland

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  • Olsztyn,
    Poland

    Site Not Available

  • Warszawa,
    Poland

    Site Not Available

  • Wroclaw,
    Poland

    Site Not Available

  • Saint-Petersburg, Poselok Pesochny
    Russian Federation

    Site Not Available

  • Ufa, Republic Of Bashkortostan
    Russian Federation

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  • Kazan, Republic Tatrstan
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

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  • empty

    Moscow area,
    Russian Federation

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  • Moskva,
    Russian Federation

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  • St.Petersburg,
    Russian Federation

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  • Johannesburg, Gauteng
    South Africa

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  • Pretoria, Gauteng
    South Africa

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  • empty

    Gauteng, Johannesburg
    South Africa

    Site Not Available

  • Amanzimtoti, Kwa Zulu Natal
    South Africa

    Site Not Available

  • Bloemfontein,
    South Africa

    Site Not Available

  • Cape Town,
    South Africa

    Site Not Available

  • Badalona,
    Spain

    Site Not Available

  • Barcelona,
    Spain

    Site Not Available

  • Marbella,
    Spain

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  • Pamplona,
    Spain

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  • Salamanca,
    Spain

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  • Santiago de Compostela,
    Spain

    Site Not Available

  • Valencia,
    Spain

    Site Not Available

  • Changhua City,
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation - Chiayi Branch

    Chiayi County,
    Taiwan

    Site Not Available

  • Chiayi County 613,
    Taiwan

    Site Not Available

  • empty

    Chiayi County 613,,
    Taiwan

    Site Not Available

  • Tainan,
    Taiwan

    Site Not Available

  • Taipei,
    Taiwan

    Site Not Available

  • Taoyuan County,
    Taiwan

    Site Not Available

  • empty

    Fatih, Istanbul
    Turkey

    Site Not Available

  • empty

    Kurupelit, Samsun
    Turkey

    Site Not Available

  • Ankara,
    Turkey

    Site Not Available

  • Istanbul,
    Turkey

    Site Not Available

  • Samsun,
    Turkey

    Site Not Available

  • Truro, Cornwall
    United Kingdom

    Site Not Available

  • Aberdeen, Scotland
    United Kingdom

    Site Not Available

  • Glasgow, Scotland
    United Kingdom

    Site Not Available

  • Sutton, Surrey
    United Kingdom

    Site Not Available

  • 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

    Site Not Available

  • Leicester,
    United Kingdom

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  • Lincoln,
    United Kingdom

    Site Not Available

  • Liverpool,
    United Kingdom

    Site Not Available

  • London,
    United Kingdom

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  • Manchester,
    United Kingdom

    Site Not Available

  • Norfolk,
    United Kingdom

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  • Northwood,
    United Kingdom

    Site Not Available

  • empty

    Northwood, Middx,
    United Kingdom

    Site Not Available

  • Nottingham,
    United Kingdom

    Site Not Available

  • Oxford,
    United Kingdom

    Site Not Available

  • Romford,
    United Kingdom

    Site Not Available

  • Southampton,
    United Kingdom

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Gilbert, Arizona
    United States

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • Burbank, California
    United States

    Site Not Available

  • Duarte, California
    United States

    Site Not Available

  • Fresno, California
    United States

    Site Not Available

  • Fullerton, California
    United States

    Site Not Available

  • La Jolla, California
    United States

    Site Not Available

  • Long Beach, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Sacramento, California
    United States

    Site Not Available

  • San Luis Obispo, California
    United States

    Site Not Available

  • Santa Barbara, California
    United States

    Site Not Available

  • Santa Monica, California
    United States

    Site Not Available

  • Stanford, California
    United States

    Site Not Available

  • Colorado Springs, Colorado
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Lonetree, Colorado
    United States

    Site Not Available

  • Washington, District of Columbia
    United States

    Site Not Available

  • empty

    Washington, D.C., District of Columbia
    United States

    Site Not Available

  • Fort Myers, Florida
    United States

    Site Not Available

  • Jacksonville, Florida
    United States

    Site Not Available

  • University of Miami Sylvester Comprehensive Cancer

    Maimi, Florida 33136
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Orlando, Florida
    United States

    Site Not Available

  • Lawrenceville, Georgia
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Maywood, Illinois
    United States

    Site Not Available

  • Niles, Illinois
    United States

    Site Not Available

  • Zion, Illinois
    United States

    Site Not Available

  • Fort Wayne, Indiana
    United States

    Site Not Available

  • Goshen, Indiana
    United States

    Site Not Available

  • Indianapolis, Indiana
    United States

    Site Not Available

  • Iowa City, Iowa
    United States

    Site Not Available

  • Fairway, Kansas
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • Bethesda, Maryland
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Ann Arbor, Michigan
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • Minneapolis, Minnesota
    United States

    Site Not Available

  • Rochester, Minnesota
    United States

    Site Not Available

  • Saint Louis, Missouri
    United States

    Site Not Available

  • Springfield, Missouri
    United States

    Site Not Available

  • empty

    St. Louis, Missouri
    United States

    Site Not Available

  • Lincoln, Nebraska
    United States

    Site Not Available

  • Omaha, Nebraska
    United States

    Site Not Available

  • Las Vegas, Nevada
    United States

    Site Not Available

  • Basking Ridge, New Jersey
    United States

    Site Not Available

  • Hackensack, New Jersey
    United States

    Site Not Available

  • Morristown, New Jersey
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • Albany, New York
    United States

    Site Not Available

  • Bronx, New York
    United States

    Site Not Available

  • Commack, New York
    United States

    Site Not Available

  • empty

    NYC, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • empty

    New York City, New York
    United States

    Site Not Available

  • Rockville Centre, New York
    United States

    Site Not Available

  • empty

    The Bronx, New York
    United States

    Site Not Available

  • Charlotte, North Carolina
    United States

    Site Not Available

  • Raleigh, North Carolina
    United States

    Site Not Available

  • Bismarck, North Dakota
    United States

    Site Not Available

  • Mid Dakota Clinic

    Bismark, North Dakota 58501
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Columbus, Ohio
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Eugene, Oregon
    United States

    Site Not Available

  • Hershey, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Charleston, South Carolina
    United States

    Site Not Available

  • Greenville, South Carolina
    United States

    Site Not Available

  • Chattanooga, Tennessee
    United States

    Site Not Available

  • Knoxville, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Tyler, Texas
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • empty

    Alexandria, Virginia
    United States

    Site Not Available

  • Fairfax, Virginia
    United States

    Site Not Available

  • Richmond, Virginia
    United States

    Site Not Available

  • Kennewick, Washington
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Vancouver, Washington
    United States

    Site Not Available

  • Yakima, Washington
    United States

    Site Not Available

  • Morgantown, West Virginia
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

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