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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02993783.
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 enrolled 17 participants. Participants will be randomly assigned (by chance,
like flipping a coin) to one of the two treatment groups:
- Vedolizumab 300 mg
- Vedolizumab 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 participants 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
participants in the study will be determined.
This multi-center trial will be conducted in multiple countries. The overall time to
participate in this study is 32 weeks. Participants will make multiple visits to the
clinic after last dose of study drug for a follow-up assessment.
Lead OrganizationMillennium Pharmaceuticals, Inc.