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Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 14 to 13
    • Primary completion date: Jul 2026 to Dec 2026
    • Collaborators: 15 to 12
    v32
  2. Primary completion date: Jul 2025 to Jul 2026
    • Study sites: 16 to 14
    v31
  3. Primary completion date: Dec 2024 to Jul 2025v30
  4. Primary completion date: Apr 2024 to Dec 2024v29
  5. Primary completion date: Jan 2024 to Apr 2024v28
Show 26 earlier versionsHide 26 earlier versions
  1. Primary completion date: May 2023 to Jan 2024v27
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2022 to May 2023
    • Study sites revised (16)
    v26
  3. Site contacts updated at 1 of 16 sites
    • Collaborators revised (15)
    v25
  4. Study sites revised (16)v24
  5. Interventions: Cyclosporins (Drug), Fludarabine (Drug), Mycophenolate mofetil (Drug), alemtuzumab (Biological) to Cyclosporins (Drug), Fludarabine (Drug), Mycophenolate mofetil (Drug), Tacrolimus (Drug), alemtuzumab (Biological)
    • Eligibility criteria expanded, about 6 words
    v23
  6. Site contacts updated at 1 of 16 sitesv22
  7. Study sites revised (16)
    • Collaborators revised (15)
    v21
  8. Study sites: 15 to 16
    • Collaborators: 14 to 15
    v20
  9. Collaborators: 13 to 14v19
  10. Study sites: 14 to 15v18
  11. Study sites: 12 to 14
    • Collaborators: 11 to 13
    v17
  12. Study sites: 11 to 12
    • Collaborators: 9 to 11
    v16
  13. Primary completion date: Dec 2019 to Dec 2022
    • Study sites: 10 to 11
    v15
  14. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 20 to 40
    • Site details revised at 10 of 10 sites
    v14
  15. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v13
  16. Study sites: 9 to 10
    • Collaborators: 8 to 9
    v12
  17. Collaborators: 5 to 8v11
  18. Site contacts updated at 1 of 9 sitesv10
  19. Study sites: 6 to 9v9
  20. Study sites: 5 to 6
    • Collaborators: 4 to 5
    v8
  21. Study sites: 4 to 5
    • Collaborators: 3 to 4
    v7
  22. Enrollment target: 10 to 20v6 Show 7 more changesShow less
    • Primary completion date: Oct 2017 to Dec 2019
    • Primary endpoints: 2 to 1
    • Study sites: 1 to 4
    • Study completion date: Oct 2032 to Dec 2034
    • Secondary endpoints: 8 to 10
    • Collaborators expanded, about 12 words
    • Eligibility criteria expanded, about 3 words
  23. 3 versions Re-verified since May 20, 2014, no change to tracked fieldsv3-v5
  24. Eligibility criteria expanded, about 24 wordsv2
  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.
Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically causing failure of the blood system. Lung disease, liver disease and cancer are other frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood system but can make the lung and liver disease and risk of cancer worse, because of DNA damaging agents such as alkylators and radiation that are typically used in the procedure. Based on the biology of DC, we hypothesize that it may be possible to avoid these DNA damaging agents in patients with DC, and still have a successful BMT. In this protocol we will test whether a regimen that avoids DNA alkylators and radiation can permit successful BMT without compromising survival in patients with DC.
Trial Details
NCT Number NCT01659606
Lead Sponsor Boston Children's Hospital
Collaborators: Dana-Farber Cancer Institute, Children's Hospital Medical Center, Cincinnati, Fred Hutch/University of Washington/Seattle Children's Cancer Consortium, Baylor College of Medicine, Children's Hospital of Philadelphia, University of Wisconsin, Madison, Karolinska University Hospital, Hackensack Meridian Health, Oslo University Hospital, Children's Mercy Hospital Kansas City, University of Chicago, Massachusetts General Hospital
Conditions
(from sponsor)		 Dyskeratosis Congenita, Hoyeraal Hreidarsson Syndrome, Revesz Syndrome, Aplastic Anemia
Related terms Anemia, Aplastic, Bone Marrow Failure Disorders, Dyskeratosis Congenita, Hoyeraal Hreidarsson syndrome, Revesz Debuse syndrome
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov