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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 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.

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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.

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

FieldValue
Enrollment Target 260 participants
Start Date 2011-10-10
Est. Completion 2015-10-15
Phase Phase 3

Sponsor

Neovii Biotech

5 total trials

What the Registry Record Tells You About NCT01295710

The ClinicalTrials.gov registry entry for NCT01295710 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 205-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (27% higher). The listed sponsor is Neovii Biotech, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.