NCT01295710

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Neovii Biotech · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• GVHD
• Adult Acute Myeloid Leukemia
• Adult Acute Lymphoid Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
BIOLOGICAL	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Timeline

• Start date: 2011-10-10
• Primary completion: 2015-10-15
• Completion: 2015-10-15
• First posted: 2011-02-14
• Last updated: 2019-04-09
• Results posted: 2019-03-20

Locations

28 sites across 2 countries: United States, Australia