At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 260 enrolled
Drug / intervention
US-ATG-F +1 morebiological
Likely dose
US-ATG-F 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating US-ATG-F and Placebo for GVHD and 3 related conditions. Completed, enrolled 260 participants across 28 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia, Myelodysplastic Syndrome
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartOct 2011
Primary CompletionOct 2015
TodayJul 2026
First PostedFeb 14, 2011
Enrollment StartOct 10, 2011
Primary CompletionOct 15, 2015
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 15.4 years ago
Interventions
US-ATG-Fbiological
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Placebobiological
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation