Last updated on September 2017

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)


Brief description of study

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.

Detailed Study Description

The drug being tested in this study is called vedolizumab. This study will look at the tolerability and effectiveness of vedolizumab IV in participants with acute intestinal GvHD who have received no systemic therapy for the treatment of acute GvHD (prophylaxis acceptable) other than corticosteroids. The study will enroll approximately 38 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups: - Vedolizumab IV 300 mg - Vedolizumab IV 600 mg All participants will be infused intravenously at the same time each day throughout the study. Vedolizumab IV will be administered on Days 1, 15, 43, 71, and 99. After approximately 10 patients are enrolled at each dose level and have data available from the Day 28 evaluation, safety, tolerability, efficacy, and pharmacokinetic (PK), results will be assessed for each dose level, and the appropriate dose for subsequent patients in the study will be determined. The cohort at the chosen dose level will then be expanded by approximately 18 additional evaluable patients to further assess the tolerability and effectiveness of vedolizumab. Both dose levels may be expanded based on accumulating results, if necessary. This multi-center trial will be conducted in multiple countries. The overall time to participate in this study is 36 months. Participants will make multiple visits to the clinic after last dose of study drug for a follow-up assessment.

Clinical Study Identifier: NCT02993783

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Massachusetts General Hospital
Boston, MA United States
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Washington University
Saint Louis, MO United States
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Mount Sinai - PRIME
Lake Success, NY United States
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OSU - James Comprehensive Cancer Center
Columbus, OH United States
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Baylor University Medical Center
Dallas, TX United States
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Seattle Cancer Care Alliance
Seattle, WA United States
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ZNA Stuivenberg
Antwerpen, Belgium
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AZ Sint-Jan Brugge
Brugge, Belgium
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CHU Nantes - H tel Dieu
Nantes cedex 1, France
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Hopital Claude Huriez - CHU Lille
Lille cedex, France
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H pital Saint-Antoine
Paris cedex 12, France
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Oslo Universitetssykehus - Rikshospitalet
Oslo, Norway
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Sk nes Universitetssjukhus, Lund
Lund, Sweden
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Akademiska Sjukhuset
Uppsala, Sweden
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