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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
343
Vedolizumab placebo-matching IV infusion.
Vedolizumab IV infusion.
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.
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
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.
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
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.
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
Nonrelapse Mortality (NRM)
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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
...and 129 more locations
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
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.
Time frame: From the date of first dose of study drug to first documented death up to Day +180
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.
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