A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)
Public ClinicalTrials.gov record NCT05600426. 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 Trial Comparing Unrelated Donor Bone Marrow Transplantation With Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant. Regular treatment for patients with aplastic anemia who have a matched sibling (brother or sister), or family donor is a bone marrow transplant. Patients without a matched family donor normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone marrow transplant (BMT) is used as a secondary treatment in patients who did not get better with IST, had their disease come back, or a new worse disease replaced it (like leukemia). This trial will compare time from randomization to failure of treatment or death from any cause of IST versus URD BMT when used as initial therapy to treat SAA. The trial will also assess whether health-related quality of life and early markers of fertility differ between those randomized to URD BMT or IST, as well as assess the presence of marrow failure-related genes and presence of gene mutations associated with MDS or leukemia and the change in gene signatures after treatment in both study arms. This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for treatment of SAA.
Study identification
- NCT ID
- NCT05600426
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 53 participants
Conditions and interventions
Conditions
Interventions
- cyclosporine Drug
- Matched Unrelated Donor Hematopoetic Stem Cell Transplant Procedure
- horse anti-thymocyte globulin (ATG) Drug
- rabbit anti-thymocyte globulin (ATG) Drug
- Methotrexate Drug
- Fludarabine Drug
- Cyclophosphamide Drug
- low-dose total body irradiation (TBI) Radiation
- Immunosuppressive Therapy (IST) Procedure
Drug · Procedure · Radiation
Eligibility (public fields only)
- Age range
- 0 Years to 25 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 24, 2023
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2029
- Last update posted
- Jul 29, 2026
2023 – 2029
United States locations
- U.S. sites
- 50
- U.S. states
- 31
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas | Little Rock | Arkansas | 72202 | — |
| Loma Linda | Loma Linda | California | 92354 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Children's Hospital & Research Center Oakland | Oakland | California | 94609 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Stanford | Palo Alto | California | 94304 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Nemours Children's Hospital, Delaware | Wilmington | Delaware | 19803 | — |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Children's Hospital of Atlanta/Emory | Atlanta | Georgia | 30322 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University Hospital/Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Children's Hospital NOLA | New Orleans | Louisiana | 70118 | — |
| Maine Health | Scarborough | Maine | 04074 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| Mayo Clinic Rochestser | Rochester | Minnesota | 55902 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | — |
| Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Levine Children's Hospital | Charlotte | North Carolina | 28203 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Methodist Healthcare | San Antonio | Texas | 78229 | — |
| University of Utah/Primary Children's Hospital | Salt Lake City | Utah | 84112 | — |
| Children's Hospital of the King's Daughter | Norfolk | Virginia | 23507 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05600426, 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 Jul 29, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05600426 live on ClinicalTrials.gov.