Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes Undergoing Allogeneic Hematopoietic Cell Transplantation.

Trial Profile

Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes Undergoing Allogeneic Hematopoietic Cell Transplantation.

Recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Mar 2018

At a glance

  • Drugs PRO 140 (Primary)
  • Indications Graft-versus-host disease
  • Focus Therapeutic Use
  • Sponsors CytoDyn
  • Most Recent Events

    • 14 Mar 2018 According to a CytoDyn media release, the Independent Data Monitoring Committee (IDMC) for the Companys PRO 140 Phase 2 trial in graft-versus-host disease (GvHD) has completed a planned interim analysis of trial data on the first 10 patients enrolled. Based on that meeting, the Company plans to amend the trial protocol and to obtain concordance for the amended protocol from the U.S. Food and Drug Administration (FDA).
    • 14 Dec 2016 Status changed from not yet recruiting to recruiting.
    • 12 Apr 2016 Status changed from planning to not yet recruiting.
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