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Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 17 words
    • Study description revised
    • Publications: details revised at 9 of 9 entries
  2. Primary completion date: Aug 31, 2026 to Aug 31, 2027
    • Study completion date: Aug 31, 2027 to Aug 31, 2028
    v20
  3. Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Study completion date: Aug 31, 2026 to Aug 31, 2027
    v19
  4. 7 versions Re-verified since Aug 30, 2021, no change to tracked fieldsv12-v18
  5. Primary completion date: Aug 31, 2022 to Aug 31, 2025
    • Study completion date: Aug 31, 2023 to Aug 31, 2026
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. 2 versions Re-verified since Nov 13, 2019, no change to tracked fieldsv9-v10
  2. Primary completion date: Aug 2021 to Aug 31, 2022
    • Study completion date: Apr 2022 to Aug 31, 2023
    v8
  3. Primary completion date: Aug 2020 to Aug 2021
    • Study completion date: Sep 2022 to Apr 2022
    • Start date: Sep 2016 to Sep 9, 2016
    v7
  4. Primary completion date: Aug 2019 to Aug 2020
    • Study completion date: Sep 2021 to Sep 2022
    v6
  5. Primary completion date: Aug 2018 to Aug 2019
    • Study completion date: Sep 2020 to Sep 2021
    v5
  6. 2 versions Re-verified since Dec 12, 2016, no change to tracked fieldsv3-v4
  7. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study completion date: Aug 2020 to Sep 2020
    • Start date: Aug 2016 to Sep 2016
    • Study description revised
    • Site details revised at 2 of 2 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Severe aplastic anemia is a rare and serious form of bone marrow failure related to an immune-mediated mechanism that results in severe pancytopenia and high risk for infections and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance of survival; however, a response rate with just immunosuppression for those patients lacking suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1/3 of patients are cured, 1/3 are dependent on long term immunosuppression, and the other 1/3 relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical donor for transplantation has good response rates and significantly lower rates of acute and chronic GVHD.
Trial Details
NCT Number NCT02828592
Lead Sponsor Northside Hospital, Inc.
Conditions
(from sponsor)		 Severe Aplastic Anemia
Related terms Anemia, Aplastic
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov