Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 1 for:    millennium C25003
Previous Study | Return to List | Next Study

Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. ) Identifier:
First received: October 19, 2012
Last updated: September 29, 2016
Last verified: September 2016
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)

Condition Intervention Phase
Hodgkin Lymphoma
Drug: brentuximab vedotin
Drug: doxorubicin
Drug: bleomycin
Drug: vinblastine
Drug: dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Modified progression free survival (mPFS) per independent review facility (IRF) [ Time Frame: Date of randomization to mPFS event, for approximately 3 to 5 years ]

Secondary Outcome Measures:
  • Overall survival rate [ Time Frame: Date of randomization to the date of death, for approximately 5 to 7 years ]
    Date of randomization to the date of death

Enrollment: 1334
Study Start Date: November 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A + AVD
A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 mg/kg plus doxorubicin 25 mg/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2
Drug: brentuximab vedotin
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle
Other Names:
  • SGN-35
Drug: doxorubicin
Doxorubicin: 25 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: Adriamycin
Drug: vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: dacarbazine
Dacarbazine (DTIC): 375 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: DTIC
Active Comparator: ABVD
ABVD consists of doxorubicin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2
Drug: doxorubicin
Doxorubicin: 25 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: Adriamycin
Drug: bleomycin
Bleomycin: 10 units/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: dacarbazine
Dacarbazine (DTIC): 375 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: DTIC


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Treatment-naïve
  • Histologically confirmed classical Hodgkin Lymphoma (HL)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Bidimensional measurable disease

Exclusion Criteria:

  • Nodular lymphocyte predominant Hodgkin lymphoma
  • Cerebral/meningeal disease, including signs and symptoms of progressive multifocal leukoencephalopathy (PML)
  • Pulmonary diffusion capacity > 25% lower than normal predicted value
  • Sensory or motor peripheral neuropathy
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01712490

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Gilbert, Arizona, United States
Tucson, Arizona, United States
United States, California
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
United States, Colorado
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lonetree, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
United States, Georgia
Lawrenceville, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Maywood, Illinois, United States
Niles, Illinois, United States
Zion, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
Goshen, Indiana, United States
Indianapolis, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kansas
Fairway, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
Bethesda, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
United States, Missouri
Springfield, Missouri, United States
St. Louis, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Basking Ridge, New Jersey, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Albany, New York, United States
Bronx, New York, United States
Commack, New York, United States
New York City, New York, United States
New York, New York, United States
NYC, New York, United States
Rochester, New York, United States
Rockville Centre, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
United States, North Dakota
Bismarck, North Dakota, United States
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Eugene, Oregon, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Greenville, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Fairfax, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Kennewick, Washington, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Yakima, Washington, United States
United States, West Virginia
Morgantown, West Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Australia, New South Wales
Kingswood, New South Wales, Australia
St Leonards, New South Wales, Australia
Westmead, New South Wales, Australia
Australia, Queensland
South Brisbane, Queensland, Australia
Australia, South Australia
Bedford Park, South Australia, Australia
Australia, Tasmania
Hobart, Tasmania, Australia
Australia, Victoria
East Melbourne, Victoria, Australia
Geelong, Victoria, Australia
Heidelberg, Victoria, Australia
Parkville, Victoria, Australia
Australia, Western Australia
Perth, Western Australia, Australia
Antwerpen, Belgium
Brugge, Belgium
Gent, Belgium
Salvador, Bahia, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santo Andre, Sao Paulo, Brazil
Rio De Janeiro, Brazil
Sao paulo, Brazil
Canada, Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Mb, Manitoba, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Czech Republic
Hradec Kralove, Czech Republic
Prague, Czech Republic
Praha 10, Czech Republic
Aalborg, Denmark
Aarhus C, Denmark
Copenhagen, Denmark
Herlev, Denmark
Odense C, Denmark
Roskilde, Denmark
Argenteuil, Cedex, France
La Tronche, France
Limoges, France
Paris, France
Hong Kong
Lai Chi Kok, Kowloon, Hong Kong
Hong Kong, Hong Kong
Tuen Mun, New Territories, Hong Kong
Budapest, Hungary
Debrecen, Hungary
Gyor, Hungary
Pecs, Hungary
Szeged, Hungary
Modena, Emilia-Romagna, Italy
Roma, Lazio, Italy
Alessandria, Italy
Bologna, Italy
Cagliari, Italy
Cuneo, Italy
Genova, Italy
Milano, Italy
Napoli, Italy
Rionero in Volture, Italy
Rome, Italy
Rozzano, Milano, Italy
Torrette di Ancona, Italy
Minami-ku, Fukuoka-city, Japan
Higashi-ku, Fukuoka, Japan
Minami-ku, Hiroshima-city, Japan
Showamachi, Maebashi-city, Japan
Chikusa-ku, Nagoya, Japan
Suita, Osaka Prefecture, Japan
Aoba-ku, Sendai-city, Japan
Chuo-ku, Japan
Isehara-shi, Japan
Koto-ku, Japan
Korea, Republic of
Goyang, Gyeonggi, Korea, Republic of
Hwasun-gun, Jeollanam-do, Korea, Republic of
Seocho-gu, Seoul, Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Incheon, Korea, Republic of
Jeonju, Korea, Republic of
Seoul, Korea, Republic of
Bergen, Norway
Oslo, Norway
Gdansk, Poland
Katowice, Poland
Krakow, Poland
Lodz, Poland
Olsztyn, Poland
Warszawa, Poland
Wroclaw, Poland
Russian Federation
Saint-Petersburg, poselok Pesochny, Russian Federation
Ufa, Republic of Bashkortostan, Russian Federation
Kazan, Republic Tatrstan, Russian Federation
Moscow area, Russian Federation
Moscow, Russian Federation
Moskva, Russian Federation
St.Petersburg, Russian Federation
South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Amanzimtoti, Kwa Zulu Natal, South Africa
Bloemfontein, South Africa
Cape Town, South Africa
Pretoria, South Africa
Badalona, Spain
Barcelona, Spain
Marbella, Spain
Pamplona, Spain
Salamanca, Spain
Santiago de Compostela, Spain
Valencia, Spain
Changhua City, Taiwan
Chiayi County 613,, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan County, Taiwan
Ankara, Turkey
Istanbul, Turkey
Samsun, Turkey
United Kingdom
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, Middx, United Kingdom
Nottingham, United Kingdom
Oxford, United Kingdom
Romford, United Kingdom
Southampton, United Kingdom
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01712490     History of Changes
Other Study ID Numbers: C25003
2011-005450-60 ( EudraCT Number )
U1111-1161-4937 ( Registry Identifier: WHO )
12/LO/1950 ( Registry Identifier: NRES )
JapicCTI-142491 ( Registry Identifier: JapicCTI )
REec-2013-0114 ( Registry Identifier: REec )
1025002760 ( Registry Identifier: TCTIN )
C25003CTID ( Other Identifier: Israel )
Study First Received: October 19, 2012
Last Updated: September 29, 2016

Keywords provided by Takeda:
Hodgkin Lymphoma
Hodgkins Lymphoma
Antibody, Monoclonal
Antibody-Drug Conjugate
Antigens, CD-30
Lymphoma, Classical

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Liposomal doxorubicin
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on April 26, 2017