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

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

Outcome

Met primary endpoint

paper The primary end point was met; Kaplan-Meier (95% confidence interval) estimated rates of lower-GI aGVHD-free survival by day +180 PMID 38844797 ↗

registry analysis (superiority test); Placebo vs Vedolizumab 300 mg; p <0.001; Hazard Ratio (HR) 0.45 (95% CI 0.27 to 0.73); Log Rank NCT03657160 ↗

Publications

Chen YB, Mohty M, Zeiser R, Teshima T, Jamy O, Maertens J, Purtill D, Chen J, Cao H, Rossiter G, Jansson J, Floisand Y. Vedolizumab for the prevention of intestinal acute GVHD after allogeneic hematopoietic stem cell transplantation: a randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2277-2287. doi: 10.1038/s41591-024-03016-4. Epub 2024 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vedolizumab	Monoclonal antibody	300 mg	Intravenous