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NCT01295710 · ClinicalTrials.gov registry record · Phase 3
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
A Phase 3 study of Myelodysplastic Syndrome and GvHD, sponsored by Neovii Biotech.
- Completed
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT01295710: Completed Phase 3 study of Myelodysplastic Syndrome and GvHD, sponsored by Neovii Biotech.
NCT01295710 is a Phase 3 study of Myelodysplastic Syndrome and GvHD that has completed, run by Neovii Biotech. The registered enrollment target is 260 participants, above the 205-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01295710, a Phase 3 study of Myelodysplastic Syndrome and GvHD, has completed, sponsored by Neovii Biotech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD, or death from any cause
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL US-ATG-F
Study Locations (20)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
California
- City of Hope - Duarte
- Stanford University Medical Center, BMT - Stanford
Florida
- University of Florida Shands Cancer Center - Gainesville
- Moffitt Cancer Center - Tampa
Illinois
- University of Chicago Medical Center - Chicago
- Loyola University Medical Center - Maywood
North Carolina
- University of North Carolina Hospitals - Chapel Hill
- Duke University Medical Center - Durham
Pennsylvania
- Penn State Hershey Cancer Institute - Hershey
- Abramson Cancer Center of the University at Perlman Center for Advanced Medicine - Philadelphia
Kansas
- University of Kansas Medical Center - Westwood
Louisiana
- Tulane University Health Sciences Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2011-10-10 |
| Est. Completion | 2015-10-15 |
| Phase | Phase 3 |
What the finished NCT01295710 record still lists
NCT01295710 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 205-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (27% higher).
The record links to 4 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01295710 names 20 study sites across 13 states, led by Massachusetts, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01295710 about?
NCT01295710 is a clinical study titled "Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)". 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.
What is the current status of trial NCT01295710?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2011-10-10. Estimated completion is 2015-10-15.
What conditions does trial NCT01295710 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, GvHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia.
What interventions are being tested in trial NCT01295710?
The interventions under investigation include: Placebo (BIOLOGICAL), US-ATG-F (BIOLOGICAL).
Who is sponsoring clinical trial NCT01295710?
This trial is sponsored by Neovii Biotech, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01295710 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
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Where NCT01295710's enrollment target sits among peer trials
260 14th of 134 higher than 121 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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