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
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
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.
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:
This multi-center trial will be conducted Worldwide. The overall time to participate in this study is 12 months.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35294, United States
Los Angeles, California 90095, United States
Chicago, Illinois 60611, United States
New York, New York 10032, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1093AAS, Argentina
Fortaleza, Ceará 60430-380, Brazil
São Paulo, 01246-000, Brazil
Mainz, Rhineland-Palatinate 55131, Germany
Patras, Peloponnese 26504, Greece
Reggio Calabria, Calabria 89122, Italy
Bunkyo-Ku, Tokyo 113-8677, Japan
Seoul, Gyeonggi-do 03080, South Korea
Daegu, Gyeongsangbuk-do 41944, South Korea
Daegu, Gyeongsangbuk-do 42601, South Korea
Las Palmas de Gran Canaria, LAS Palmas 35010, Spain