Trial record 1 of 1 for:    millennium C25003
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Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Millennium Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01712490
First received: October 19, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Millennium Pharmaceuticals, Inc.:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival rate [ Time Frame: Date of randomization to the date of death, for approximately 5 to 7 years ] [ Designated as safety issue: No ]
    Date of randomization to the date of death


Estimated Enrollment: 1040
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:
  • ADCETRIS®
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01712490

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Oncology Associates--HOPE Division Recruiting
Tucson, Arizona, United States
United States, California
Roy and Patricia Disney Family Cancer Center Recruiting
Burbank, California, United States, 91505
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
St. Jude Heritage Recruiting
Fullerton, California, United States, 92835
Pacific Shores Medical Group (Main) Recruiting
Long Beach, California, United States
Coastal Integrative Cancer Care Recruiting
San Luis Obispo, California, United States, 93401
Santa Barbara Hematology Oncology Recruiting
Santa Barbara, California, United States, 93108
UCLA Department of Medicine Hematology/Oncology Recruiting
Santa Monica, California, United States, 90404
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
United States, Colorado
Colorado Cancer Research Program Recruiting
Colorado Springs, Colorado, United States
Colorado Cancer Research Program Recruiting
Denver, Colorado, United States
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States
United States, Florida
Florida Cancer Specialists [RCH] Recruiting
Fort Myers, Florida, United States, 33916
Integrated Community Oncology Network Recruiting
Jacksonville, Florida, United States, 32256
University of Miami Sylvester Comprehensive Cancer Recruiting
Miami, Florida, United States, 33136
MD Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Maryland
UMGCC Recruiting
Baltimore, Maryland, United States
Johns Hopkins University Recruiting
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Harvard Medical School - Massachusetts General Hospital (MGH) Recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University - Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Medicine Hematology Office Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States
United States, Nevada
Comprehensive Care Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Memorial Sloan-Kettering Cancer Center @ Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States
United States, New York
"Montefiore Medical Center Recruiting
Bronx, New York, United States
St. Luke's Roosevelt Hospital Center Recruiting
New York, New York, United States
Columbia University Recruiting
New York, New York, United States
Mount Sinai Hospital Recruiting
New York City, New York, United States
Memorial Sloan-Kettering Cancer Center Recruiting
New York City, New York, United States, 10065
University of Rochester Recruiting
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center @ Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
United States, North Carolina
Rex Cancer Center Recruiting
Raleigh, North Carolina, United States
United States, North Dakota
Mid Dakota Clinic Recruiting
Bismarck, North Dakota, United States, 58501
United States, Ohio
Oncology Hematology Care-BAM Recruiting
Cincinnati, Ohio, United States, 45242
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States
United States, Pennsylvania
Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina - Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 296601
United States, Tennessee
Tennessee Oncology Chattanooga Recruiting
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute (SCRI) Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Columbia Basin Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Nepean Cancer Centre Recruiting
Kingswood, New South Wales, Australia, 2747
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Haematology and Oncology Clinics of Australia (HOCA) Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Australia
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Australia
The Geelong Hospital Recruiting
Geelong, Australia
Royal Perth Hospital Recruiting
Perth, Australia
Royal North Shore Hospital Recruiting
St Leonards, Australia
Belgium
ZNA Stuivenberg - Hematology department Recruiting
Antwerpen, Belgium, 2060
Algemeen Ziekenhuis Sint- Jan Recruiting
Brugge, Belgium
Universitair Ziekenhuis Gent - Hematology department Recruiting
Gent, Belgium
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
BCCA Centre for Lymphoid Cancer Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada
Queen Elizabeth II Health Sciences Center Recruiting
Halifax, Canada
McGill University Dept of Oncology Recruiting
Montreal, Canada
Czech Republic
Fakultni nemocnice Hradec Kralove - Site Recruiting
Hradec Kralove, Czech Republic, 50005
General University Hospital Recruiting
Prague, Czech Republic
Fakultni nemocnice Kralovske Vinohrady, Clinical Hematology department Recruiting
Prague, Czech Republic
Denmark
Aalborg Hospital Recruiting
Aalborg, Denmark, 9000
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Rigshospitalet Copenhagen Recruiting
Copenhagen, Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Odense University Hospital Recruiting
Odense, Denmark, 5000
Roskilde Sygehus Recruiting
Roskilde, Denmark
France
Chu Grenoble Recruiting
Grenoble, France
Hungary
Egyesitett Szent Istvan es Szent Laszlo Kh Rendeloint Recruiting
Budapest, Hungary
National Institute of Oncology Recruiting
Budapest, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Belgyogyaszati Recruiting
Debrecen, Hungary, 4032
University of Pecs Recruiting
Pécs, Hungary
University of Szeged Recruiting
Szeged, Hungary
Italy
S.C. Ematologia Recruiting
Alessandria, Italy
Istituto di Ematologia "L. e A. Seragnoli" Recruiting
Bologna, Italy, 40138
"Ospedale Oncologico di Recruiting
Cagliari, Italy
S.C. Ematologia Recruiting
Cuneo, Italy
Ematologia 1 Recruiting
Genova, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori Recruiting
Milano, Italy
Centro Oncologico Modenese Recruiting
Modena, Italy
Azienda Ospedaliera Universitaria "Federico II" Recruiting
Napoli, Italy
IRCCS Centro di Riferimento Oncologico della Basilicata Recruiting
Rionero in Volture, Italy
Regina Elena Cancer Institute Recruiting
Rome, Italy
Istituto clinico HUMANITAS - HUMANITAS Cancer Center Recruiting
Rozzano Milano, Italy
Clinica di Ematologia Recruiting
Torrette di Ancona, Italy
Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
National Cancer Center Recruiting
Goyang, Korea, Republic of
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Ewha Womans University Hospital Recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Seoul St Mary's Hospital (The Catholic University of Korea) Recruiting
Seoul, Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland
MCM Recruiting
Krakow, Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Recruiting
Lódz, Poland
SP ZOZ MSWiA Warminsko-Mazurskie Centrum Onkologii w Olsztynie Recruiting
Olsztyn, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Recruiting
Warszawa, Poland, 02-781
Instytut Hematologii I Transfuzjologii w Warszawie Recruiting
Warszawa, Poland
SPSK nr 1 we Wroclawiu Recruiting
Wroclaw, Poland
Spain
Institut Catalá d'Oncologia Recruiting
Badalona, Spain
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Hospital Clinic I Providence De Barcelona Recruiting
Barcelona, Spain, 08036
Institut Municipal d Assistencia Sanitaria (IMAS) - Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Universitari Quirón Dexeus Recruiting
Barcelona, Spain
Hospital Costa del Sol Recruiting
Marbella, Spain
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain
Hospital Clínico Santiago Recruiting
Santiago de Compostela, Spain
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain
Taiwan
Changhua Christian Hospital (CCH) Recruiting
Changhua City, Taiwan
Chang Gung Medical Foundation - Chiayi Branch Recruiting
Chiayi County, Taiwan
National Cheng Kung University Hospital (NCKUH) Recruiting
Tainan, Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation - LinKou Branch Recruiting
Taoyuan County, Taiwan
United Kingdom
Royal Cornwall Hospitals NHS Trust Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
James Paget University Hospitals NHS Foundation Trust Recruiting
Norfolk, England, United Kingdom, NR31 6LA
Queen's Hospital, Romford Recruiting
Romford, England, United Kingdom, RM7 OAG
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
The Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Queen Elizabeth Hospital, Birmingham Recruiting
Birmingham, United Kingdom
Kent & Canterbury Hospital, Canterbury Recruiting
Canterbury, United Kingdom, CT1 3PA
University Hospital of Wales, Cardiff Recruiting
Cardiff, United Kingdom
Royal Devon & Exeter NHS Foundation Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Raigmore Hospital, Inverness Recruiting
Inverness, United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Lincoln County Hospital Recruiting
Lincoln, United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
Aintree University Hospital NHS Foundation Trust Recruiting
Liverpool, United Kingdom
Guys and St. Thomas' Hospital, London Recruiting
London, United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom
St Georges Hospital Recruiting
London, United Kingdom
Queen Mary University of London Recruiting
London, United Kingdom, EC1M 6BQ
Department of Medical Oncology Recruiting
Manchester, United Kingdom, M20 4BX
Mount Vernon Cancer Centre Recruiting
Northwood, Middx, United Kingdom
Nottingham University Hospital NHS Trust Recruiting
Nottingham, United Kingdom
Cancer and Haematology Research Centre Recruiting
Oxford, United Kingdom, OX3 7LE
Cancer Research UK Centre Recruiting
Southampton, United Kingdom, SO16 6YD
Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01712490     History of Changes
Other Study ID Numbers: C25003, 2011-005450-60
Study First Received: October 19, 2012
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Millennium Pharmaceuticals, Inc.:
Hodgkin Lymphoma
Hodgkin's Lymphoma
Antibody, Monoclonal
Antibody-Drug Conjugate
Antigens, CD-30
Immunotherapy
Lymphoma
Lymphoma, Classical

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Bleomycin
Doxorubicin
Liposomal doxorubicin
Dacarbazine
Vinblastine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 19, 2014