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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03657160

Public ClinicalTrials.gov record NCT03657160. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 6:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT03657160
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Enrollment
343 participants

Conditions and interventions

Interventions

  • Vedolizumab Placebo Drug
  • Vedolizumab Drug

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 5, 2019
Primary completion
Feb 6, 2022
Completion
May 8, 2022
Last update posted
Jun 5, 2023

2019 – 2022

United States locations

U.S. sites
27
U.S. states
16
U.S. cities
21
Facility City State ZIP Site status
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama 35294
David Geffen School of Medicine at University of California Los Angeles Los Angeles California 90095
Children's Healthcare of Atlanta Atlanta Georgia 30322
Emory University - Winship Cancer Institute Atlanta Georgia 30322
Augusta University Georgia Cancer Center Augusta Georgia 30912
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois 60611
Loyola University Medical Center Maywood Illinois 60153
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202
University of Kentucky Chandler Medical Center Lexington Kentucky 40536
Marlene and Stewart Greenebaum Cancer Center Baltimore Maryland 21201
Massachusetts General Hospital Boston Massachusetts 02114
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Boston Children's Hospital Boston Massachusetts 02215
Dana Farber Cancer Institute Boston Massachusetts 02215
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201
Mayo Clinic - Rochester Rochester Minnesota 55905
Roswell Park Cancer Institute Buffalo New York 14263
Roswell Park Comprehensive Cancer Center Buffalo New York 14263
Cohen Children's Medical Center New Hyde Park New York 11040
Weill Cornell Medical College New York New York 10021
Columbia University Medical Center - The Columbia Center for Translational Immunology New York New York 10032
University of North Carolina Hospitals Chapel Hill North Carolina 27514
Oregon Health and Science University Portland Oregon 97239
Medical University of South Carolina Charleston South Carolina 29425
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246
University of Virginia Health System Charlottesville Virginia 22908
Massey Cancer Center Richmond Virginia 23298

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 112 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03657160, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 5, 2023 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03657160 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →