drugset / Trial / NCT03657160

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

NCT03657160

Phase 3 Completed 343 enrolled Millennium Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2019-02-06
Primary completion
2022-02-07
Completion
2022-05-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous