Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)
Public ClinicalTrials.gov record NCT00562497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Prochymal® versus placebo in combination with corticosteroids as initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients with previously untreated acute GVHD and the historical published data define an expected 35% complete response (CR) at Day +28 using this therapy.
Study identification
- NCT ID
- NCT00562497
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 192 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2008 (Actual)
- Primary completion
- Jul 14, 2009 (Actual)
- Completion
- May 20, 2010 (Actual)
- Last update posted
- Jan 19, 2022
2008 – 2010
United States locations
- U.S. sites
- 45
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham (UAB) Hospital | Birmingham | Alabama | 35249 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| University of California Medical Center | San Francisco | California | 94143 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| Northwestern Center for Clinical Research | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | — |
| St. Francis Cancer Center | Indianapolis | Indiana | 46237 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tufts New England Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Medical Center | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Kansas City Cancer Center | Lee's Summit | Missouri | 64064 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| New York Presbyterian Hospital | New York | New York | 10065 | — |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27514 | — |
| Duke University Health System | Durham | North Carolina | 27705 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Jewish Hospital | Cincinnati | Ohio | 45236 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Abramson Cancer Center, University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Oncology Hematology Association | Pittsburgh | Pennsylvania | 15232 | — |
| University of Pittsburgh Cancer Centers | Pittsburgh | Pennsylvania | 15232 | — |
| Medical University of South Carolina(MUSC) | Charleston | South Carolina | 29425 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Transplant Institute | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00562497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 19, 2022 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00562497 live on ClinicalTrials.gov.