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HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

Study acronym: RAFA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 2025 to Dec 2026 Completion date: Jul 2027 to Dec 2028v15 Show 1 more changeShow less
    • Completion date: Jul 2027 to Dec 2028
  2. Re-verified, no change to tracked fieldsv14
  3. Primary completion date: Jul 2024 to Jul 2025 Completion date: Jul 2026 to Jul 2027v13 Show 1 more changeShow less
    • Completion date: Jul 2026 to Jul 2027
  4. 3 versions Re-verified since Apr 7, 2022, no change to tracked fieldsv10-v12
  5. Site details revised at 1 of 3 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: May 2019 to Jul 2024 Completion date: May 2020 to Jul 2026v7 Show 1 more changeShow less
    • Completion date: May 2020 to Jul 2026
  3. Study sites: 2 to 3v6
  4. Enrollment target: 40 to 70 Study sites: 1 to 2 · Collaborators: 1 to 2v5 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Dec 4, 2015, no change to tracked fieldsv3-v4
  6. Eligibility criteria expanded, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to determine whether the use of lower doses of busulfan and the elimination of cyclosporine will further reduce transplant-related side effects for patients with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or matched unrelated donors following a preparative regimen of busulfan, fludarabine, anti-thymocyte globulin and cyclophosphamide.
Trial Details
NCT Number NCT02143830
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: Memorial Sloan Kettering Cancer Center, Fred Hutchinson Cancer Center
Conditions Fanconi Anemia, Severe Marrow Failure, Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML)
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov