Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation

PHASE3CompletedINTERVENTIONAL
Enrollment

343

Participants

Timeline

Start Date

February 6, 2019

Primary Completion Date

February 7, 2022

Study Completion Date

May 9, 2022

Conditions
Hematopoietic Stem Cells
Interventions
DRUG

Vedolizumab Placebo

Vedolizumab placebo-matching IV infusion.

DRUG

Vedolizumab

Vedolizumab IV infusion.

Trial Locations (139)

100

National Taiwan University Hospital, Taipei

333

Chang Gung Memorial Hospital, Taoyuan District

404

China Medical University Hospital, Taichung

807

Kaohsiung Medical University Hospital, Kaohsiung City

970

Buddhist Tzu Chi General Hospital, Hualien City

2010

Saint Vincent's Hospital Sydney, Darlinghurst

2060

Ziekenhuisnetwerk Stuivenberg, Antwerp

3000

Universitair Ziekenhuis Leuven, Leuven

3050

The Royal Melbourne Hospital, Parkville

3084

Austin Health, Heidelberg

4006

Royal Brisbane and Women's Hospital, Herston

4020

Ordensklinikum Linz Elisabethinen, Linz

4031

Universitatsspital Basel, Basel

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

6150

Fiona Stanley Hospital, Murdoch

8091

Universitatsspital Zurich, Zurich

10021

Weill Cornell Medical College, New York

10032

Columbia University Medical Center - The Columbia Center for Translational Immunology, New York

11040

Cohen Children's Medical Center, New Hyde Park

11259

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

12462

University General Hospital of Athens Attikon, Athens

13620

Seoul National University Bundang Hospital, Seongnam-si

14263

Roswell Park Cancer Institute, Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

21201

Marlene and Stewart Greenebaum Cancer Center, Baltimore

22908

University of Virginia Health System, Charlottesville

23298

Massey Cancer Center, Richmond

24105

Universitaetsklinikum Schleswig-Holstein - Campus Kiel, Kiel

26504

University Regional General Hospital of Patras, Patras

27514

University of North Carolina Hospitals, Chapel Hill

28034

Hospital Universitario Ramon Y Cajal, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

29425

Medical University of South Carolina, Charleston

30008

Hospital General Universitario Morales Meseguer, Murcia

30120

Hospital Universitario Virgen de la Arrixaca, Murcia

30174

Ospedale dell'Angelo, Mestre

30322

Children's Healthcare of Atlanta, Atlanta

Emory University - Winship Cancer Institute, Atlanta

30912

Augusta University Georgia Cancer Center, Augusta

31008

Clinica Universidad de Navarra, Pamplona

35010

Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria

35015

Chungnam National University Hospital, Daejeon

35033

Hopital Pontchaillou, Rennes

35294

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham

37007

Hospital Universitario de Salamanca, Salamanca

40536

University of Kentucky Chandler Medical Center, Lexington

40705

Taichung Veterans General Hospital, Taichung

41013

Hospital Universitario Virgen del Rocio, Seville

41944

Kyungpook National University Hospital, Daegu

42472

Daegu Catholic University Medical Center, Daegu

42601

Keimyung University Dongsan Hospital, Daegu

44093

Centre Hospitalier Universitaire Nantes - Hotel Dieu, Nantes

46010

Hospital Clinico Universitario de Valencia, Valencia

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

48201

Barbara Ann Karmanos Cancer Institute, Detroit

49241

Pusan National University Hospital, Pusan

55131

Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz

55905

Mayo Clinic - Rochester, Rochester

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona

60153

Loyola University Medical Center, Maywood

60590

Universitatsklinikum Frankfurt, Frankfurt am Main

60611

Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago

63100

Ospedale Mazzoni, Ascoli Piceno

64460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey

65125

Presidio Ospedaliero di Pescara, Pescara

68167

Universitatsmedizin Mannheim, Mannheim

70124

Azienda Ospedaliera Policlinico di Bari, Bari

70176

Diakonie-Klinikum Stuttgart, Stuttgart

73039

Azienda Ospedaliera Cardinale G. Panico, Tricase

75012

Hopital Saint-Antoine, Paris

75013

Groupe Hospitalier Pitie-Salpetriere, Paris

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

75475

Hopital Saint Louis, Paris

84101

Soroka University Medical Center, Beersheba

87042

Centre Hospitalier Universitaire de Limoges, Limoges

89122

Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria

90095

David Geffen School of Medicine at University of California Los Angeles, Los Angeles

95124

Policlinico Universitario di Catania, Catania

97239

Oregon Health and Science University, Portland

119228

National University Hospital, Singapore

125167

National Research Center for Hematology, Moscow

169608

Singapore General Hospital, Singapore

188770

Raffles Hospital, Singapore

540042

Spitalul Clinic Judetean de Urgenta Targu Mure, Târgu Mureş

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

3109601

Rambam Health Care Campus - Rambam Medical Center, Haifa

5265601

The Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9112001

Hadassah Medical Center, Jerusalem

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Boston Children's Hospital, Boston

Dana Farber Cancer Institute, Boston

C1093AAS

Fundacion Favaloro Hospital Universitario, Ciudad Autonoma de Buenos Aires

C1199ABB

Hospital Italiano de Buenos Aires, Buenos Aires

X5014KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

60430-380

Hospital Universitario Walter Cantidio - Universidade Federal do Ceara, Fortaleza

80510-130

Instituto do Cancer e Transplante de Curitiba, Curitiba

14784-400

Hospital de Cancer de Barretos, Barretos

01246-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

01509-010

Fundacao Antonio Prudente - A.C.Camargo Cancer Center, São Paulo

03102-006

Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncolgia, São Paulo

08270-070

Hospital Santa Marcelina, São Paulo

R3E 0V9

CancerCare Manitoba, Winnipeg

S7N 4H4

Saskatchewan Cancer Agency, Saskatoon

80054 CEDEX 1

Centre Hospitalier Universitaire Amiens-Picardie, Amiens

75473 cedex 15

Hopital Necker-Enfants Malades, Paris

01307

Universitatsklinikum Carl Gustav Carus Dresden, Dresden

06120

Universitatsklinikum Halle, Halle

20089'

Istituto Clinico Humanitas Humanitas Cancer Center, Milan

453-8511

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya

812-8582

Kyushu University Hospital, Fukuoka

730-8619

Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima

060-8648

Hokkaido University Hospital, Sapporo

700-8558

Okayama University Hospital, Okayama

411-8777

Shizuoka Cancer Center, Nakatogari

329-0498

Jichi Medical University Hospital, Shimotsuke

113-8677

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Bunkyo-Ku

545-8586

Osaka City University Hospital, Osaka

0372

Oslo University Hospital - Rikshospitalet, Oslo

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

1099-023

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria, Lisbon

4200-072

Instituto Portugues de Oncologia do Porto Francisco Gentil, Porto

022328

Institutul Clinic Fundeni, Bucharest

03080

Seoul National University Hospital, Seoul

02841

Korea University Anam Hospital, Seoul

03722

Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea - Seoul St. Mary's Hospital, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

221 85

Skanes Universitetssjukhus i Lund, Lund

141 86

Karolinska Universitetssjukhuset, Stockholm

L7 8XP

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

EC1M 6BQ

Barts Health NHS Trust, London

W12 0HS

Imperial College Healthcare NHS Trust, London

S10 2JF

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

CF14 4XW

Cardiff and Vale University Health Board, Cardiff

All Listed Sponsors
lead

Millennium Pharmaceuticals, Inc.

INDUSTRY