At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 enrolled
Drug / intervention
Vedolizumab Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Vedolizumab Placebo and Vedolizumab for Hematopoietic Stem Cells. Completed, enrolled 343 participants across 139 sites in 27 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematopoietic Stem Cells
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Norway, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartFeb 2019
Primary CompletionFeb 2022
Study CompletionMay 2022
TodayJul 2026
First PostedSep 4, 2018
Enrollment StartFeb 6, 2019
Primary CompletionFeb 7, 2022
Study CompletionMay 9, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.8 years ago
Interventions
Vedolizumab Placebodrug
Vedolizumab placebo-matching IV infusion.
Vedolizumabdrug
Vedolizumab IV infusion.