TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)
Public ClinicalTrials.gov record NCT03959241. 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 Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 1703; Progress III); Companion Study: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (BMT CTN 1801; Mi-Immune)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation. 1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.
Study identification
- NCT ID
- NCT03959241
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 431 participants
Conditions and interventions
Interventions
- Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate Procedure
- Tacrolimus Drug
- Methotrexate Drug
- Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide Procedure
- Mycophenolate Mofetil Drug
- Cyclophosphamide Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jun 25, 2019 (Actual)
- Primary completion
- Sep 19, 2022 (Actual)
- Completion
- Sep 19, 2022 (Actual)
- Last update posted
- Apr 4, 2024
2019 – 2022
United States locations
- U.S. sites
- 39
- U.S. states
- 23
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Stanford Hospital and Clinics | Stanford | California | 94305 | — |
| University of Florida College of Medicine (Shands) | Gainesville | Florida | 32610 | — |
| University of Miami | Miami | Florida | 33136 | — |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33624 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Blood & Marrow Transplant Program at Northside Hospital | Atlanta | Georgia | 30342 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Loyola University | Maywood | Illinois | 60153 | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Indiana BMT - St. Francis Hospital | Indianapolis | Indiana | 46327 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242-1009 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Johns Hopkins University | Baltimore | Maryland | 21231 | — |
| Dana Farber Cancer Institute/Brigham & Women's Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana Farber Cancer Institute/Massachusetts General Hospital Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute, Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Washington University/Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10174 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| University Hospitals of Cleveland/Case Western | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State/Arthur G. James Cancer Hospital | Columbus | Ohio | 43210 | — |
| Oregon Health & Science University | Portland | Oregon | 97239-3098 | — |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Baylor College of Medicine/The Methodist Hospital | Houston | Texas | 77030 | — |
| University of Texas, MD Anderson Cancer Research Center | Houston | Texas | 77030 | — |
| Virginia Commonwealth University, MCV Hospital | Richmond | Virginia | 23298 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | — |
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53792-5156 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53211 | — |
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 NCT03959241, 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 Apr 4, 2024 · Synced Oct 20, 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 NCT03959241 live on ClinicalTrials.gov.