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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2024

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GRAPHITE
  • Sponsors Takeda; Takeda Oncology
  • Most Recent Events

    • 01 Aug 2024 Results assessing Vedolizumab for the prevention of intestinal acute GVHD after allogeneic hematopoietic stem cell transplantation published in the Nature Medicine.
    • 04 Feb 2024 This trial has been completed in Italy,according to European Clinical Trials Database record.
    • 20 Feb 2023 According to a Takeda pharmaceuticals media release, data were presented as a late-breaking abstract at The 2023 Tandem Meetings Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood & Marrow Transplant Research.

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