Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
NCT ID: NCT03657160
Last Updated: 2023-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
343 participants
INTERVENTIONAL
2019-02-06
2022-05-09
Brief Summary
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Detailed Description
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The study will enroll approximately 558 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need) along with background GvHD prophylaxis regimen:
* Vedolizumab 300 mg
* Placebo (dummy inactive intravenous infusion)
This multi-center trial will be conducted Worldwide. The overall time to participate in this study is 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
Vedolizumab Placebo
Vedolizumab placebo-matching IV infusion.
Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
Vedolizumab
Vedolizumab IV infusion.
Interventions
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Vedolizumab Placebo
Vedolizumab placebo-matching IV infusion.
Vedolizumab
Vedolizumab IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must undergo deoxyribose nucleic acid (DNA)-based human leukocyte antigen (HLA) matching and be 8 of 8 or 7 of 8 HLA-matched (singe allele or antigen mismatch at HLA-A, -B, and -C, and HLA-DRB1 is allowable) unrelated hematopoietic stem cell transplantation (HSCT) from either peripheral blood or bone marrow stem cells for a hematologic malignancy or myeloproliferative disorder.
3. For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned.
4. Allo-HSCT eligible (meeting institutional criteria)-participants planned medical care should include aGvHD prophylaxis with a combination of calcineurin inhibitor (CNI) (cyclosporine \[CYS\] or tacrolimus \[TAC\]) and methotrexate (MTX) or CNI and mycophenolate mofetil (MMF). With the exception of antithymocyte globulin (ATG) (antithymocyte globulin-Fresenius \[ATG-F\] or thymoglobulin), all other therapies, approved or investigational, for GvHD prophylaxis are excluded.
5. Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2 for participants aged \>=18 years at randomization or \>=60 % using the Karnofsky performance status for adolescent participants aged \>=16 years at randomization or the Lansky performance status for adolescent participants aged 12 to \< 16 years at randomization.
Exclusion Criteria
2. Planned umbilical cord blood transplant or planned to receive posttransplant cyclophosphamide, in vivo or ex vivo T cell-depleted hematopoietic stem cells (HSCs) with the exception of ATG (ATG-F or thymoglobulin).
3. Planned allo-HSCT for nonmalignant hematological disorders (example, aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).
12 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
David Geffen School of Medicine at University of California Los Angeles
Los Angeles, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Augusta University Georgia Cancer Center
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Cohen Children's Medical Center
New Hyde Park, New York, United States
Weill Cornell Medical College
New York, New York, United States
Columbia University Medical Center - The Columbia Center for Translational Immunology
New York, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Fundacion Favaloro Hospital Universitario
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Saint Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, Austria
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Ziekenhuisnetwerk Stuivenberg
Antwerp, , Belgium
Hospital Universitario Walter Cantidio - Universidade Federal do Ceara
Fortaleza, Ceará, Brazil
Instituto do Cancer e Transplante de Curitiba
Curitiba, Paraná, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, , Brazil
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
São Paulo, , Brazil
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncolgia
São Paulo, , Brazil
Hospital Santa Marcelina
São Paulo, , Brazil
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Saskatchewan Cancer Agency
Saskatoon, Saskatchewan, Canada
Hopital Pontchaillou
Rennes, Brittany Region, France
Centre Hospitalier Universitaire de Limoges
Limoges, Limousin, Lorraine, France
Centre Hospitalier Universitaire Nantes - Hotel Dieu
Nantes, Pays de la Loire Region, France
Centre Hospitalier Universitaire Amiens-Picardie
Amiens, Picardie, France
Hopital Saint-Antoine
Paris, Île-de-France Region, France
Groupe Hospitalier Pitie-Salpetriere
Paris, Île-de-France Region, France
Hopital Necker-Enfants Malades
Paris, Île-de-France Region, France
Hopital Saint Louis
Paris, Île-de-France Region, France
Universitatsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
Diakonie-Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Universitatsklinikum Halle
Halle, Saxony-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, Germany
University General Hospital of Athens Attikon
Athens, Attica, Greece
University Regional General Hospital of Patras
Patras, Peloponnese, Greece
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, Hungary
Soroka University Medical Center
Beersheba, Beersheba, Israel
Rambam Health Care Campus - Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Calabria, Italy
Azienda Ospedaliera Cardinale G. Panico
Tricase, Lecce, Italy
Ospedale Mazzoni
Ascoli Piceno, The Marches, Italy
Ospedale dell'Angelo
Mestre, Venezia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliera Policlinico di Bari
Bari, , Italy
Policlinico Universitario di Catania
Catania, , Italy
Istituto Clinico Humanitas Humanitas Cancer Center
Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Presidio Ospedaliero di Pescara
Pescara, , Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Shizuoka Cancer Center
Nakatogari, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-Ku, Tokyo, Japan
Osaka City University Hospital
Osaka, , Japan
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Oslo University Hospital - Rikshospitalet
Oslo, , Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Lisbon, , Portugal
Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto, , Portugal
Spitalul Clinic Judetean de Urgenta Targu Mure
Târgu Mureş, Mureș County, Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Sverdlovsk Oblast, Russia
National Research Center for Hematology
Moscow, , Russia
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Raffles Hospital
Singapore, , Singapore
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do, South Korea
Keimyung University Dongsan Hospital
Daegu, Gyeongsangbuk-do, South Korea
Pusan National University Hospital
Pusan, Gyeongsangnam-do, South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, LAS Palmas, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Skanes Universitetssjukhus i Lund
Lund, Skåne County, Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Universitatsspital Basel
Basel, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Buddhist Tzu Chi General Hospital
Hualien City, Hualien, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, England, United Kingdom
Barts Health NHS Trust
London, England, United Kingdom
Imperial College Healthcare NHS Trust
London, England, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, England, United Kingdom
Cardiff and Vale University Health Board
Cardiff, Wales, United Kingdom
Countries
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References
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Chen YB, Mohty M, Zeiser R, Teshima T, Jamy O, Maertens J, Purtill D, Chen J, Cao H, Rossiter G, Jansson J, Floisand Y. Vedolizumab for the prevention of intestinal acute GVHD after allogeneic hematopoietic stem cell transplantation: a randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2277-2287. doi: 10.1038/s41591-024-03016-4. Epub 2024 Jun 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002141-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-184221
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1216-2319
Identifier Type: REGISTRY
Identifier Source: secondary_id
Vedolizumab-3035
Identifier Type: -
Identifier Source: org_study_id
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