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RATinG (Risk Adapted Therapy in acute GvHD): investigating the use of lenzilumab for treating high-risk acute graft versus host disease following allogeneic stem cell transplantation

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Trial Profile

RATinG (Risk Adapted Therapy in acute GvHD): investigating the use of lenzilumab for treating high-risk acute graft versus host disease following allogeneic stem cell transplantation

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 17 Mar 2023

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At a glance

  • Drugs Lenzilumab (Primary)
  • Indications Graft-versus-host disease
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms RATinG
  • Sponsors Humanigen

Most Recent Events

  • 05 May 2022 Accoding to a Humanigen media release, University of Birmingham, UK notified that amended Investigational Medicinal Product Dossier has been accepted by Medicines & Healthcare products Regulatory Agency for this study. The company enrolled first patient in the second quarter.
  • 08 Feb 2022 Status changed from planning to recruiting.
  • 11 Nov 2021 Accoding to a Humanigen media release, If an independent data monitoring committee deem the second stage to be feasible, then the trial will progress to its double-blind, randomized (1:1), second stage, which will enroll a minimum of 220 patients. A second interim analysis is planned to assess futility based upon the 28-day response rate to the first infusion in the first 150 evaluable patients.

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