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A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)

Study acronym: TransIT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Boston Children's Hospital to Boston Children's Hospital
    • Secondary endpoints: details revised at 18 of 27 entries
    • Site details revised at 27 of 52 sites
  2. 4 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv54-v57
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 234 to confirmed 53
    • Study sites: 51 to 52
    v53
  4. Study sites: 50 to 51v52
  5. Site contacts updated at 2 of 50 sitesv51
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  1. Site contacts updated at 1 of 50 sitesv50
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  3. Site contacts updated at 2 of 49 sitesv48
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  5. Site contacts updated at 1 of 47 sitesv46
  6. Study sites revised (47)v45
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  8. Site contacts updated at 1 of 46 sitesv43
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  37. Re-verified, no change to tracked fieldsv14
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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05600426
Lead Sponsor Boston Children's Hospital
Collaborators: Center for International Blood and Marrow Transplant Research, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), North American Pediatric Aplastic Anemia Consortium, Pediatric Transplantation and Cellular Therapy Consortium, Blood and Marrow Transplant Clinical Trials Network
Conditions
(from sponsor)		 Severe Aplastic Anemia
Related terms Anemia, Aplastic
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov