A Randomized, Prospective, Double Blind, Placebo-Controlled, Phase 3 Study of US-ATG-F Prophylaxis as a Supplement to Standard of Care Prophylaxis to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients after Allogeneic Stem Cell Transplantation from Unrelated Donors.

Trial Profile

A Randomized, Prospective, Double Blind, Placebo-Controlled, Phase 3 Study of US-ATG-F Prophylaxis as a Supplement to Standard of Care Prophylaxis to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients after Allogeneic Stem Cell Transplantation from Unrelated Donors.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2016

At a glance

  • Drugs Antithymocyte globulin (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Neovii Biotech
  • Most Recent Events

    • 13 May 2016 Planned End Date changed from 1 Feb 2022 to 1 Dec 2016.
    • 13 May 2016 Planned primary completion date changed from 1 Feb 2016 to 1 Sep 2016.
    • 11 Jan 2016 Planned End Date changed from 1 Feb 2016 to 1 Feb 2022 as reported by ClinicalTrils.gov record.
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