NCT03657160

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic Stem Cells

Interventions

Type	Name	Description
DRUG	Vedolizumab Placebo	Vedolizumab placebo-matching IV infusion.
DRUG	Vedolizumab	Vedolizumab IV infusion.

Timeline

• Start date: 2019-02-06
• Primary completion: 2022-02-07
• Completion: 2022-05-09
• First posted: 2018-09-04
• Last updated: 2023-06-06
• Results posted: 2023-04-14

Locations

139 sites across 27 countries: United States, Argentina, 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

Regulatory

• FDA-regulated drug study