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A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

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Trial Profile

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs Leronlimab (Primary)
  • Indications Graft-versus-host disease
  • Focus Therapeutic Use
  • Sponsors CytoDyn

    • Most Recent Events

    • 13 Jan 2022 Status changed from suspended to discontinued due to lack of enrolment.
    • 29 Jan 2021 Status changed from recruiting to suspended due to the lack of patients during the COVID-19 pandemic, according to a CytoDyn media release
    • 05 Mar 2020 According to a CytDyn media release, the next review f data by the independent data monitoring committee (iDMC) will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days.
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