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Vedolizumab and Basiliximab for Steroid-Resistant GI aGVHD
NCT06066840Phase 4
Key facts
- Status
- Recruiting
- Start
- Aug 2022
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- First Affiliated Hospital of Soochow University
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- vedolizumab
- Conditions
- Acute Graft-Versus-Host Disease (aGvHD)
01
Overview
Phase 4, open-label, single-arm trial of vedolizumab in Acute Graft-Versus-Host Disease (aGvHD), sponsored by First Affiliated Hospital of Soochow University. Primary endpoint: Overall Response Rate at 28 days. Started Aug 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Vedolizumab + Basiliximab
Vedolizumab and Basiliximab combination with rapid steroid reduction.
03
Who it enrols
Adults aged 18-65 with grade 3-4 steroid-resistant acute graft-versus-host disease with lower gastrointestinal involvement, ECOG score <=3, and no severe complications or uncontrolled infections.
04
Endpoints
Primary
Overall Response Rate
Secondary
Overall Response Rate
Duration of Response
Overall Survival
Event-Free Survival
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