Clinical Trial VICCBMT1218

Title

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

Principal Investigator(s)

Madan Jagasia

Details

  • Protocol No. VICCBMT1218
  • Open Date: 09/04/2012
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective is to demonstrate the efficacy of US-ATG-F versus Placebo when combined with standard GVHD prophylaxis (TAC plus MTX) in moderate to severe chronic GVHD-free survival after allogeneic stem cell transplantation from unrelated donors.
  • Disease Sites: Leukemia; Myelodysplastic Syndrome
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: US-ATG-F
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01295710
  • Secondary Protocol No: IV-ATG-SCT-01

Description

Eligibility

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