Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
Public ClinicalTrials.gov record NCT01106833. 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 II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone and Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN Protocol #0801)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.
Study identification
- NCT ID
- NCT01106833
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 151 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Apr 2010 (Actual)
- Primary completion
- Feb 14, 2017 (Actual)
- Completion
- Jun 2018 (Actual)
- Last update posted
- Dec 5, 2018
2010 – 2018
United States locations
- U.S. sites
- 31
- U.S. states
- 22
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010-3000 | — |
| University of California San Diego Medical Center | La Jolla | California | 92093 | — |
| Stanford Hospital and Clinics | Stanford | California | 94305 | — |
| University of Florida College of Medicine (Shands) | Gainesville | Florida | 32610-0277 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Blood & Marrow Transplant Program at Northside Hospital | Atlanta | Georgia | 30342 | — |
| University of Chicago | Chicago | Illinois | 60637-1470 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Johns Hopkins University | Baltimore | Maryland | 21231 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48105-2967 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University, Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10174 | — |
| Mayo Clinic | Rochester | New York | 55905 | — |
| University of North Carolina Hospital at Chapel Hill | Chapel Hill | North Carolina | 27599-7305 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Jewish Hospital BMT Program | Cincinnati | Ohio | 45236 | — |
| University Hospitals of Cleveland/ Case Western | Cleveland | Ohio | 44106-5061 | — |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University (A) and (P) | Portland | Oregon | 97239-3098 | — |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Texas/MD Anderson CRC | Houston | Texas | 77030 | — |
| Texas Transplant Institute | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University/MCV Hospitals | Richmond | Virginia | 23298 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792-5156 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01106833, 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 Dec 5, 2018 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01106833 live on ClinicalTrials.gov.