Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
Public ClinicalTrials.gov record NCT00406393. 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.
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Official title
A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.
Study identification
- NCT ID
- NCT00406393
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 304 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 60 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
- Nov 2006 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Oct 2015 (Actual)
- Last update posted
- Jan 4, 2023
2006 – 2015
United States locations
- U.S. sites
- 23
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| UCSD Medical Center | La Jolla | California | 92093 | — |
| Stanford Hospital and Clinics | Stanford | California | 94305 | — |
| University of Florida College of Medicine (Shands) | Gainesville | Florida | 32610 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242-1009 | — |
| DFCI/Brigham & Women's Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0914 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University/Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| University Hospitals of Cleveland/Case Western | Cleveland | Ohio | 44106-5061 | — |
| Ohio State, Arthur G. James Cancer Hospital | Columbus | Ohio | 43210 | — |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | — |
| Texas Transplant Institute | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University/MCV Hospital | Richmond | Virginia | 23298 | — |
| University of Wisconsin Hospital & 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00406393, 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 4, 2023 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00406393 live on ClinicalTrials.gov.