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Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
NCT01295710 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01295710
The ClinicalTrials.gov registry entry for NCT01295710 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neovii Biotech, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01295710 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Massachusetts, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01295710?
The interventions under investigation include: Placebo (BIOLOGICAL), US-ATG-F (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01295710?
This trial is sponsored by Neovii Biotech, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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