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

Primary Purpose

Hematopoietic Stem Cells

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vedolizumab Placebo
Vedolizumab
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematopoietic Stem Cells focused on measuring Drug Therapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must be greater than or equal to (>=) 18 years of age and, in selected countries, adolescents aged 12 years and greater and weighing >=30 kilogram (kg) at time of randomization.
  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 less than or equal to (<=) 2 for participants aged >=18 years at randomization or >=60 percent (%) using the Karnofsky performance status for adolescent subjects aged >=16 years at randomization or the Lansky performance status for adolescent participants aged 12 to less than (<) 16 years at randomization.

Exclusion Criteria:

  1. Had prior allo- HSCT.
  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).

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • David Geffen School of Medicine at University of California Los Angeles
  • Children's Healthcare of Atlanta
  • Emory University - Winship Cancer Institute
  • Augusta University Georgia Cancer Center
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Loyola University Medical Center
  • Indiana University Melvin and Bren Simon Cancer Center
  • University of Kentucky Chandler Medical Center
  • Marlene and Stewart Greenebaum Cancer Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Boston Children's Hospital
  • Dana Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • Mayo Clinic - Rochester
  • Roswell Park Cancer Institute
  • Roswell Park Comprehensive Cancer Center
  • Cohen Children's Medical Center
  • Weill Cornell Medical College
  • Columbia University Medical Center - The Columbia Center for Translational Immunology
  • University of North Carolina Hospitals
  • Oregon Health and Science University
  • Medical University of South Carolina
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • University of Virginia Health System
  • Massey Cancer Center
  • Fundacion Favaloro Hospital Universitario
  • Hospital Italiano de Buenos Aires
  • Hospital Privado Centro Medico de Cordoba
  • Saint Vincent's Hospital Sydney
  • Royal Brisbane and Women's Hospital
  • Austin Health
  • The Royal Melbourne Hospital
  • Fiona Stanley Hospital
  • Ordensklinikum Linz Elisabethinen
  • Universitair Ziekenhuis Leuven
  • Ziekenhuisnetwerk Stuivenberg
  • Hospital Universitario Walter Cantidio - Universidade Federal do Ceara
  • Instituto do Cancer e Transplante de Curitiba
  • Hospital de Cancer de Barretos
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  • Fundacao Antonio Prudente - A.C.Camargo Cancer Center
  • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncolgia
  • Hospital Santa Marcelina
  • CancerCare Manitoba
  • Saskatchewan Cancer Agency
  • Hopital Pontchaillou
  • Hopital Saint Louis
  • Hopital Saint-Antoine
  • Groupe Hospitalier Pitie-Salpetriere
  • Hopital Necker-Enfants Malades
  • Centre Hospitalier Universitaire de Limoges
  • Centre Hospitalier Universitaire Nantes - Hotel Dieu
  • Centre Hospitalier Universitaire Amiens-Picardie
  • Universitatsmedizin Mannheim
  • Diakonie-Klinikum Stuttgart
  • Universitatsklinikum Frankfurt
  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
  • Universitatsklinikum Halle
  • Universitatsklinikum Carl Gustav Carus Dresden
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • University General Hospital of Athens Attikon
  • University Regional General Hospital of Patras
  • Debreceni Egyetem Klinikai Kozpont
  • Soroka University Medical Center
  • Rambam Health Care Campus - Rambam Medical Center
  • Hadassah Medical Center
  • The Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli
  • Azienda Ospedaliera Cardinale G. Panico
  • Ospedale Mazzoni
  • Ospedale dell'Angelo
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Azienda Ospedaliera Policlinico di Bari
  • Policlinico Universitario di Catania
  • Istituto Clinico Humanitas Humanitas Cancer Center
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Presidio Ospedaliero di Pescara
  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
  • Kyushu University Hospital
  • Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
  • Hokkaido University Hospital
  • Okayama University Hospital
  • Shizuoka Cancer Center
  • Jichi Medical University Hospital
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  • Osaka City University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Kyungpook National University Hospital
  • Keimyung University Dongsan Hospital
  • Pusan National University Hospital
  • Daegu Catholic University Medical Center
  • Chungnam National University Hospital
  • Korea University Anam Hospital
  • Severance Hospital
  • Samsung Medical Center
  • The Catholic University of Korea - Seoul St. Mary's Hospital
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Oslo University Hospital - Rikshospitalet
  • Uniwersyteckie Centrum Kliniczne
  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil
  • Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
  • Instituto Portugues de Oncologia do Porto Francisco Gentil
  • Spitalul Clinic Judetean de Urgenta Targu Mure
  • Institutul Clinic Fundeni
  • Sverdlovsk Regional Clinical Hospital #1
  • National Research Center for Hematology
  • National University Hospital
  • Singapore General Hospital
  • Raffles Hospital
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario de Gran Canaria Doctor Negrin
  • Clinica Universidad de Navarra
  • Hospital Universitario Ramon Y Cajal
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital General Universitario Morales Meseguer
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitario de Salamanca
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario de Valencia
  • Skanes Universitetssjukhus i Lund
  • Karolinska Universitetssjukhuset
  • Universitatsspital Basel
  • Universitatsspital Zurich
  • Buddhist Tzu Chi General Hospital
  • Kaohsiung Medical University Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Koo Foundation Sun Yat-Sen Cancer Center
  • Chang Gung Memorial Hospital
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Barts Health NHS Trust
  • Imperial College Healthcare NHS Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • Cardiff and Vale University Health Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vedolizumab 300 mg

Arm Description

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 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).

Outcomes

Primary Outcome Measures

Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days
Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.

Secondary Outcome Measures

Intestinal aGvHD-Free and Relapse-Free Survival
Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.
Grade C-D aGvHD-Free Survival
Grade C-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death, where an event is defined as Grade C-D aGvHD any organ involvement per International Bone Marrow Transplant Registry Database (IBMTR) Severity Index for aGvHD or death. It will be censored for participants who have not had the event or have had the event after pre-specified timing, eg, last contact or Day +180 after allo-HSCT whichever occurs first.
Nonrelapse Mortality (NRM)
Non-relapse mortality is the time from the date of first study drug administration (Day-1) to death without occurrence of a relapse. Data was censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Overall Survival (OS)
Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.
Grade B-D aGvHD-Free Survival
Grade B-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to aGvHD event or death, where an event is defined as death or grade B-D any organ involvement per IBMTR Severity Index for aGvHD.

Full Information

First Posted
August 30, 2018
Last Updated
May 9, 2023
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03657160
Brief Title
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.
Detailed Description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who are undergoing allo-HSCT transplantation. This study will look at the efficacy and safety of vedolizumab in the prophylaxis of intestinal aGvHD in participants undergoing allo-HSCT transplantation. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cells
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Vedolizumab 300 mg
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Vedolizumab Placebo
Intervention Description
Vedolizumab placebo-matching IV infusion.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab
Other Intervention Name(s)
MLN0002
Intervention Description
Vedolizumab IV infusion.
Primary Outcome Measure Information:
Title
Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days
Description
Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Time Frame
From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days
Secondary Outcome Measure Information:
Title
Intestinal aGvHD-Free and Relapse-Free Survival
Description
Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.
Time Frame
From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180
Title
Grade C-D aGvHD-Free Survival
Description
Grade C-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death, where an event is defined as Grade C-D aGvHD any organ involvement per International Bone Marrow Transplant Registry Database (IBMTR) Severity Index for aGvHD or death. It will be censored for participants who have not had the event or have had the event after pre-specified timing, eg, last contact or Day +180 after allo-HSCT whichever occurs first.
Time Frame
From the date of first dose of study drug to first documented Grade C-D aGvHD or death, whichever occurs first up to Day +180
Title
Nonrelapse Mortality (NRM)
Description
Non-relapse mortality is the time from the date of first study drug administration (Day-1) to death without occurrence of a relapse. Data was censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Time Frame
From the date of first dose of study drug to first documented death without relapse, up to Day +180
Title
Overall Survival (OS)
Description
Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.
Time Frame
From the date of first dose of study drug to first documented death up to Day +180
Title
Grade B-D aGvHD-Free Survival
Description
Grade B-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to aGvHD event or death, where an event is defined as death or grade B-D any organ involvement per IBMTR Severity Index for aGvHD.
Time Frame
From the date of first dose of study drug to first documented grade B-D aGvHD or death, whichever occurs first up to Day +180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be >= 18 years of age and, in selected countries, adolescents aged 12 years and greater and weighing >=30 kilogram (kg) at time of randomization. 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. For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned. 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. 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: Had prior allo- HSCT. 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). Planned allo-HSCT for nonmalignant hematological disorders (example, aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
David Geffen School of Medicine at University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Cohen Children's Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center - The Columbia Center for Translational Immunology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Fundacion Favaloro Hospital Universitario
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5014KEH
Country
Argentina
Facility Name
Saint Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Ordensklinikum Linz Elisabethinen
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Ziekenhuisnetwerk Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Hospital Universitario Walter Cantidio - Universidade Federal do Ceara
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-380
Country
Brazil
Facility Name
Instituto do Cancer e Transplante de Curitiba
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80510-130
Country
Brazil
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
City
Sao Paulo
ZIP/Postal Code
01509-010
Country
Brazil
Facility Name
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncolgia
City
Sao Paulo
ZIP/Postal Code
03102-006
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Saskatchewan Cancer Agency
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Hopital Pontchaillou
City
Rennes Cedex 9
State/Province
Bretagne
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Saint Louis
City
Paris Cedex 10
State/Province
Ile-de-france
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Saint-Antoine
City
Paris
State/Province
Ile-de-france
ZIP/Postal Code
75012
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
State/Province
Ile-de-france
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Necker-Enfants Malades
City
Paris
State/Province
Ile-de-france
ZIP/Postal Code
75473 cedex 15
Country
France
Facility Name
Centre Hospitalier Universitaire de Limoges
City
Limoges Cedex
State/Province
Limousin, Lorraine
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier Universitaire Nantes - Hotel Dieu
City
Nantes Cedex 1
State/Province
PAYS DE LA Loire
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Universitaire Amiens-Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054 CEDEX 1
Country
France
Facility Name
Universitatsmedizin Mannheim
City
Mannheim
State/Province
Baden-wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Diakonie-Klinikum Stuttgart
City
Stuttgart
State/Province
Baden-wuerttemberg
ZIP/Postal Code
70176
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
City
Mainz
State/Province
Rheinland-pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitatsklinikum Halle
City
Halle
State/Province
Sachsen-anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
State/Province
Schleswig-holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
University General Hospital of Athens Attikon
City
Athens
State/Province
Attica
ZIP/Postal Code
12462
Country
Greece
Facility Name
University Regional General Hospital of Patras
City
Patras
State/Province
Peloponnese
ZIP/Postal Code
26504
Country
Greece
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Soroka University Medical Center
City
Beer Sheva
State/Province
Beersheba
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Health Care Campus - Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli
City
Reggio Calabria
State/Province
Calabria
ZIP/Postal Code
89122
Country
Italy
Facility Name
Azienda Ospedaliera Cardinale G. Panico
City
Tricase
State/Province
Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
Ospedale Mazzoni
City
Ascoli Piceno
State/Province
Marche
ZIP/Postal Code
63100
Country
Italy
Facility Name
Ospedale dell'Angelo
City
Mestre
State/Province
Venezia
ZIP/Postal Code
30174
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Policlinico Universitario di Catania
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Istituto Clinico Humanitas Humanitas Cancer Center
City
Milano
ZIP/Postal Code
20089'
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Presidio Ospedaliero di Pescara
City
Pescara
ZIP/Postal Code
65125
Country
Italy
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-city
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea - Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oslo University Hospital - Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto Francisco Gentil
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mure
City
Târgu-Mureş
State/Province
Mures
ZIP/Postal Code
540042
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
National Research Center for Hematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Raffles Hospital
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrin
City
Las Palmas De Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Skanes Universitetssjukhus i Lund
City
Lund
State/Province
Skane
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Universitatsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien City
State/Province
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
11259
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
State/Province
England
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
State/Province
England
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Cardiff and Vale University Health Board
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

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

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