A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Summary

The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal GvHD in participants who have undergone allo-HSCT.

Timeline

Start

2017-04-28

Primary completion

2018-05-09

Completion

2018-05-09

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy of the drug; no safety concern”

paper Overall, vedolizumab did not meet the primary efficacy endpoint (overall response at day 28) PMID 34108672 ↗

Publications

• Floisand Y, Schroeder MA, Chevallier P, Selleslag D, Devine S, Renteria AS, Mohty M, Yakoub-Agha I, Chen C, Parfionovas A, Quadri S, Jansson J, Akbari M, Chen YB. A phase 2a randomized clinical trial of intravenous vedolizumab for the treatment of steroid-refractory intestinal acute graft-versus-host disease. Bone Marrow Transplant. 2021 Oct;56(10):2477-2488. doi: 10.1038/s41409-021-01356-0. Epub 2021 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vedolizumab	Monoclonal antibody	300 mg	Intravenous
Subject	Vedolizumab	Monoclonal antibody	600 mg	Intravenous

Indications