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: 24 Oct 2017

At a glance

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

    • 24 Oct 2017 Results published in the Neovii Pharmaceuticals Media Release
    • 17 Oct 2017 Primary endpoint (First occurrence of moderate or severe chronic GVHD according to NIH criteria or death from any cause after allogeneic stem cell transplantation) has not been met as per the results published in the Journal of Clinical Oncology
    • 17 Oct 2017 Results published in the Journal of Clinical Oncology
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