Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

Myelodysplastic Syndrome Clinical Trial

Official title: Phase 3 Study of US-ATG-F 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

Status Completed

Clinical Trial Summary

The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

Clinical Trial Description

This study is randomized, prospective, double-blind, placebo-controlled, phase 3 study evaluating the prevention of moderate to severe chronic GVHD in patients undergoing bone marrow or peripheral blood stem cell transplantation from matched, unrelated donors for acute leukemia and myelodysplastic syndrome during the first year after transplant.

Patients meeting all the inclusion and none of the exclusion criteria will be randomized (1:1). All patients will receive premedication and study drug 3 days prior to transplantation. ;

Related Conditions & MeSH terms

• Adult Acute Lymphoid Leukemia
• Adult Acute Myeloid Leukemia
• GVHD
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia
• Syndrome

• NCT number: NCT01295710
• Study type: Interventional
• Source: Neovii Biotech
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2011
• Completion date: October 15, 2015