Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
Overview[ - collapse ][ - ]
| 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 | Hodgkin Lymphoma |
| Intervention | Drug: brentuximab vedotin Drug: doxorubicin Drug: bleomycin Drug: vinblastine Drug: dacarbazine |
| Phase | Phase 3 |
| Sponsor | Millennium Pharmaceuticals, Inc. |
| Responsible Party | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier | NCT01712490 |
| First Received | October 19, 2012 |
| Last Updated | January 6, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 19, 2012 |
|---|---|
| Last Updated Date | January 6, 2014 |
| Start Date | November 2012 |
| Estimated Primary Completion Date | March 2020 |
| Current 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] |
| Current 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 |
Descriptive Information[ + expand ][ + ]
| Brief Title | Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma |
|---|---|
| Official Title | A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma |
| Brief 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) |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hodgkin Lymphoma |
| Intervention | 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:
Doxorubicin: 25 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle Other Names: AdriamycinDrug: 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 Names: DTIC |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1040 |
| Estimated Completion Date | March 2020 |
| Estimated Primary Completion Date | December 2019 |
| Eligibility 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com |
| Location Countries | United States, Australia, Belgium, Canada, Czech Republic, Denmark, France, Hungary, Italy, Korea, Republic of, Poland, Spain, Taiwan, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01712490 |
|---|---|
| Other Study ID Numbers | C25003 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Millennium Pharmaceuticals, Inc. |
| Study Sponsor | Millennium Pharmaceuticals, Inc. |
| Collaborators | Seattle Genetics, Inc. |
| Investigators | Study Director: Medical Monitor Millennium Pharmaceuticals, Inc. |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama, United States, 35294 Recruiting |
|---|---|
| Arizona Oncology Associates--HOPE Division | Tucson, Arizona, United States Recruiting |
| Roy and Patricia Disney Family Cancer Center | Burbank, California, United States, 91505 Recruiting |
| City of Hope National Medical Center | Duarte, California, United States, 91010 Recruiting |
| St. Jude Heritage | Fullerton, California, United States, 92835 Recruiting |
| Pacific Shores Medical Group (Main) | Long Beach, California, United States Recruiting |
| Coastal Integrative Cancer Care | San Luis Obispo, California, United States, 93401 Recruiting |
| Santa Barbara Hematology Oncology | Santa Barbara, California, United States, 93108 Recruiting |
| UCLA Department of Medicine Hematology/Oncology | Santa Monica, California, United States, 90404 Recruiting |
| Stanford University School of Medicine | Stanford, California, United States, 94305 Recruiting |
| Colorado Cancer Research Program | Colorado Springs, Colorado, United States Recruiting |
| Colorado Cancer Research Program | Denver, Colorado, United States Recruiting |
| Georgetown University | Washington, District of Columbia, United States Recruiting |
| Florida Cancer Specialists [RCH] | Fort Myers, Florida, United States, 33916 Recruiting |
| Integrated Community Oncology Network | Jacksonville, Florida, United States, 32256 Recruiting |
| University of Miami Sylvester Comprehensive Cancer | Miami, Florida, United States, 33136 Recruiting |
| MD Anderson Cancer Center Orlando | Orlando, Florida, United States, 32806 Recruiting |
| Northwestern University | Chicago, Illinois, United States Recruiting |
| Loyola University Medical Center | Maywood, Illinois, United States, 60153 Recruiting |
| Midwestern Regional Medical Center | Zion, Illinois, United States, 60099 Recruiting |
| Indiana University Simon Cancer Center | Indianapolis, Indiana, United States, 46202 Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City, Iowa, United States, 52242 Recruiting |
| UMGCC | Baltimore, Maryland, United States Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States Recruiting |
| Center for Cancer and Blood Disorders | Bethesda, Maryland, United States, 20817 Recruiting |
| Harvard Medical School - Massachusetts General Hospital (MGH) | Boston, Massachusetts, United States, 02114 Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02215 Recruiting |
| Wayne State University - Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, United States, 48201 Recruiting |
| University of Minnesota Medicine Hematology Office | Minneapolis, Minnesota, United States, 55455 Recruiting |
| Washington University School of Medicine | St. Louis, Missouri, United States, 63110 Recruiting |
| University of Nebraska | Omaha, Nebraska, United States Recruiting |
| Comprehensive Care Centers of Nevada | Las Vegas, Nevada, United States, 89169 Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, United States, 89169 Recruiting |
| Memorial Sloan-Kettering Cancer Center @ Basking Ridge | Basking Ridge, New Jersey, United States, 07920 Recruiting |
| Hackensack University Medical Center | Hackensack, New Jersey, United States, 07601 Recruiting |
| University of New Mexico Cancer Center | Albuquerque, New Mexico, United States Recruiting |
| "Montefiore Medical Center | Bronx, New York, United States Recruiting |
| St. Luke's Roosevelt Hospital Center | New York, New York, United States Recruiting |
| Columbia University | New York, New York, United States Recruiting |
| Mount Sinai Hospital | New York City, New York, United States Recruiting |
| Memorial Sloan-Kettering Cancer Center | New York City, New York, United States, 10065 Recruiting |
| University of Rochester | Rochester, New York, United States, 14642 Recruiting |
| Memorial Sloan-Kettering Cancer Center @ Rockville Centre | Rockville Centre, New York, United States, 11570 Recruiting |
| Rex Cancer Center | Raleigh, North Carolina, United States Recruiting |
| Mid Dakota Clinic | Bismarck, North Dakota, United States, 58501 Recruiting |
| Oncology Hematology Care-BAM | Cincinnati, Ohio, United States, 45242 Recruiting |
| Ohio State University Medical Center | Columbus, Ohio, United States Recruiting |
| Abramson Cancer Center | Philadelphia, Pennsylvania, United States Recruiting |
| Medical University of South Carolina - Hollings Cancer Center | Charleston, South Carolina, United States, 29425 Recruiting |
| Saint Francis Hospital | Greenville, South Carolina, United States, 29601 Recruiting |
| Saint Francis Hospital | Greenville, South Carolina, United States, 296601 Recruiting |
| Tennessee Oncology Chattanooga | Chattanooga, Tennessee, United States Recruiting |
| Sarah Cannon Research Institute (SCRI) | Nashville, Tennessee, United States, 37203 Recruiting |
| Baylor University Medical Center | Dallas, Texas, United States Recruiting |
| MD Anderson Cancer Center | Houston, Texas, United States, 77030 Recruiting |
| University of Utah | Salt Lake City, Utah, United States, 84112 Recruiting |
| Columbia Basin Hematology and Oncology | Kennewick, Washington, United States, 99336 Recruiting |
| Virginia Mason Medical Center | Seattle, Washington, United States, 98101 Recruiting |
| West Virginia University | Morgantown, West Virginia, United States, 26506 Recruiting |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee, Wisconsin, United States, 53226 Recruiting |
| Nepean Cancer Centre | Kingswood, New South Wales, Australia, 2747 Recruiting |
| Westmead Hospital | Westmead, New South Wales, Australia, 2145 Recruiting |
| Haematology and Oncology Clinics of Australia (HOCA) | South Brisbane, Queensland, Australia, 4101 Recruiting |
| Flinders Medical Centre | Bedford Park, South Australia, Australia, 5042 Recruiting |
| Royal Hobart Hospital | Hobart, Tasmania, Australia, 7000 Recruiting |
| Austin Hospital | Heidelberg, Victoria, Australia, 3084 Recruiting |
| Royal Melbourne Hospital | Parkville, Victoria, Australia, 3050 Recruiting |
| Peter MacCallum Cancer Centre | East Melbourne, Australia Recruiting |
| The Geelong Hospital | Geelong, Australia Recruiting |
| Royal Perth Hospital | Perth, Australia Recruiting |
| Royal North Shore Hospital | St Leonards, Australia Recruiting |
| ZNA Stuivenberg - Hematology department | Antwerpen, Belgium, 2060 Recruiting |
| Algemeen Ziekenhuis Sint- Jan | Brugge, Belgium Recruiting |
| Universitair Ziekenhuis Gent - Hematology department | Gent, Belgium Recruiting |
| Cross Cancer Institute | Edmonton, Alberta, Canada Recruiting |
| BCCA Centre for Lymphoid Cancer | Vancouver, British Columbia, Canada, V5Z 4E6 Recruiting |
| Queen Elizabeth II Health Sciences Center | Halifax, Canada Recruiting |
| McGill University Dept of Oncology | Montreal, Canada Recruiting |
| Fakultni nemocnice Hradec Kralove - Site | Hradec Kralove, Czech Republic, 50005 Recruiting |
| General University Hospital | Prague, Czech Republic Recruiting |
| Fakultni nemocnice Kralovske Vinohrady, Clinical Hematology department | Prague, Czech Republic Recruiting |
| Aalborg Hospital | Aalborg, Denmark, 9000 Recruiting |
| Aarhus University Hospital | Aarhus, Denmark, 8000 Recruiting |
| Rigshospitalet Copenhagen | Copenhagen, Denmark Recruiting |
| Herlev Hospital | Herlev, Denmark, 2730 Recruiting |
| Odense University Hospital | Odense, Denmark, 5000 Recruiting |
| Roskilde Sygehus | Roskilde, Denmark Recruiting |
| Chu Grenoble | Grenoble, France Recruiting |
| Egyesitett Szent Istvan es Szent Laszlo Kh Rendeloint | Budapest, Hungary Recruiting |
| National Institute of Oncology | Budapest, Hungary Recruiting |
| Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Belgyogyaszati | Debrecen, Hungary, 4032 Recruiting |
| University of Pecs | Pécs, Hungary Recruiting |
| University of Szeged | Szeged, Hungary Recruiting |
| S.C. Ematologia | Alessandria, Italy Recruiting |
| Istituto di Ematologia "L. e A. Seragnoli" | Bologna, Italy, 40138 Recruiting |
| "Ospedale Oncologico di | Cagliari, Italy Recruiting |
| S.C. Ematologia | Cuneo, Italy Recruiting |
| Ematologia 1 | Genova, Italy Recruiting |
| Fondazione IRCCS Istituto Nazionale Dei Tumori | Milano, Italy Recruiting |
| Centro Oncologico Modenese | Modena, Italy Recruiting |
| Azienda Ospedaliera Universitaria "Federico II" | Napoli, Italy Recruiting |
| IRCCS Centro di Riferimento Oncologico della Basilicata | Rionero in Volture, Italy Recruiting |
| Regina Elena Cancer Institute | Rome, Italy Recruiting |
| Istituto clinico HUMANITAS - HUMANITAS Cancer Center | Rozzano Milano, Italy Recruiting |
| Clinica di Ematologia | Torrette di Ancona, Italy Recruiting |
| Keimyung University Dongsan Medical Center | Daegu, Korea, Republic of Recruiting |
| National Cancer Center | Goyang, Korea, Republic of Recruiting |
| Chonbuk National University Hospital | Jeonju, Korea, Republic of Recruiting |
| Ewha Womans University Hospital | Seoul, Korea, Republic of Recruiting |
| Seoul National University Hospital | Seoul, Korea, Republic of Recruiting |
| Asan Medical Center | Seoul, Korea, Republic of Recruiting |
| Seoul St Mary's Hospital (The Catholic University of Korea) | Seoul, Korea, Republic of Recruiting |
| Severance Hospital | Seoul, Korea, Republic of Recruiting |
| Samsung Medical Center | Seoul, Korea, Republic of Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk, Poland Recruiting |
| MCM | Krakow, Poland Recruiting |
| Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lódz, Poland Recruiting |
| SP ZOZ MSWiA Warminsko-Mazurskie Centrum Onkologii w Olsztynie | Olsztyn, Poland Recruiting |
| Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Warszawa, Poland, 02-781 Recruiting |
| Instytut Hematologii I Transfuzjologii w Warszawie | Warszawa, Poland Recruiting |
| SPSK nr 1 we Wroclawiu | Wroclaw, Poland Recruiting |
| Institut Catalá d'Oncologia | Badalona, Spain Recruiting |
| Hospital Santa Creu i Sant Pau | Barcelona, Spain, 08041 Recruiting |
| Hospital Clinic I Providence De Barcelona | Barcelona, Spain, 08036 Recruiting |
| Institut Municipal d Assistencia Sanitaria (IMAS) - Hospital del Mar | Barcelona, Spain, 08003 Recruiting |
| Hospital Universitari Quirón Dexeus | Barcelona, Spain Recruiting |
| Hospital Costa del Sol | Marbella, Spain Recruiting |
| Complejo Hospitalario de Navarra | Pamplona, Spain Recruiting |
| Hospital Universitario de Salamanca | Salamanca, Spain Recruiting |
| Hospital Clínico Santiago | Santiago de Compostela, Spain Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia, Spain Recruiting |
| Changhua Christian Hospital (CCH) | Changhua City, Taiwan Recruiting |
| Chang Gung Medical Foundation - Chiayi Branch | Chiayi County, Taiwan Recruiting |
| National Cheng Kung University Hospital (NCKUH) | Tainan, Taiwan Recruiting |
| Taipei Veterans General Hospital | Taipei, Taiwan Recruiting |
| Chang Gung Medical Foundation - LinKou Branch | Taoyuan County, Taiwan Recruiting |
| Royal Cornwall Hospitals NHS Trust | Truro, Cornwall, United Kingdom, TR1 3LJ Recruiting |
| James Paget University Hospitals NHS Foundation Trust | Norfolk, England, United Kingdom, NR31 6LA Recruiting |
| Queen's Hospital, Romford | Romford, England, United Kingdom, RM7 OAG Recruiting |
| Aberdeen Royal Infirmary | Aberdeen, Scotland, United Kingdom, AB25 2ZN Recruiting |
| The Beatson West of Scotland Cancer Centre | Glasgow, Scotland, United Kingdom, G12 0YN Recruiting |
| Queen Elizabeth Hospital, Birmingham | Birmingham, United Kingdom Recruiting |
| Kent & Canterbury Hospital, Canterbury | Canterbury, United Kingdom, CT1 3PA Recruiting |
| University Hospital of Wales, Cardiff | Cardiff, United Kingdom Recruiting |
| Royal Devon & Exeter NHS Foundation Trust | Exeter, United Kingdom, EX2 5DW Recruiting |
| Raigmore Hospital, Inverness | Inverness, United Kingdom Recruiting |
| Leicester Royal Infirmary | Leicester, United Kingdom Recruiting |
| Lincoln County Hospital | Lincoln, United Kingdom Recruiting |
| Royal Liverpool University Hospital | Liverpool, United Kingdom Recruiting |
| Aintree University Hospital NHS Foundation Trust | Liverpool, United Kingdom Recruiting |
| Guys and St. Thomas' Hospital, London | London, United Kingdom Recruiting |
| The Royal Marsden NHS Foundation Trust | London, United Kingdom Recruiting |
| St Georges Hospital | London, United Kingdom Recruiting |
| Queen Mary University of London | London, United Kingdom, EC1M 6BQ Recruiting |
| Department of Medical Oncology | Manchester, United Kingdom, M20 4BX Recruiting |
| Mount Vernon Cancer Centre | Northwood, Middx, United Kingdom Recruiting |
| Nottingham University Hospital NHS Trust | Nottingham, United Kingdom Recruiting |
| Cancer and Haematology Research Centre | Oxford, United Kingdom, OX3 7LE Recruiting |
| Cancer Research UK Centre | Southampton, United Kingdom, SO16 6YD Recruiting |
| Royal Marsden NHS Foundation Trust | Sutton, United Kingdom Recruiting |