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Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease

Study acronym: NYMC-571
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 102 words
    • Site contacts updated at 3 of 4 sites
    • Collaborators revised (7)
    v21
  2. Primary completion date: Dec 2024 to Dec 2026
    • Study completion date: Dec 2025 to Dec 2027
    • Site contacts updated at 1 of 4 sites
    v20
  3. Study sites revised (4)v19
  4. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Dec 2024 to Dec 2025
    v18
  5. Collaborators: 8 to 7v17
Show 15 earlier versionsHide 15 earlier versions
  1. Site details revised at 1 of 4 sitesv16
  2. Site contacts updated at 1 of 4 sitesv15
  3. Primary completion date: Dec 2022 to Dec 2023
    • Study completion date: Dec 2023 to Dec 2024
    v14
  4. Site details revised at 2 of 4 sitesv13
  5. Primary completion date: Dec 2021 to Dec 2022
    • Study completion date: Dec 2022 to Dec 2023
    v12
  6. Re-verified, no change to tracked fieldsv11
  7. Eligibility criteria expanded, about 37 words
    • Collaborators: 7 to 8
    v10
  8. Eligibility criteria shortened, about 182 wordsv9
  9. Study sites revised (4)v8
  10. Site contacts updated at 1 of 4 sites
    • Eligibility criteria shortened, about 1 word
    v7
  11. 2 versions Re-verified since Jun 20, 2018, no change to tracked fieldsv5-v6
  12. Primary completion date: Dec 2020 to Dec 2021v4 Show 6 more changesShow less
    • Study sites: 1 to 4
    • Study completion date: Dec 2021 to Dec 2022
    • Start date changed from estimate of May 2017 to Jul 1, 2017
    • Eligibility criteria expanded, about 10 words
    • Collaborators expanded, about 25 words
    • Study title expanded, about 2 words
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2016 to May 2017
    • Study sites: 0 to 1
    v3
  14. Start date: Feb 2016 to Nov 2016v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and toxicity of administering Defibrotide prophylaxis for high-risk sickle cell or beta thalassemia patients undergoing a familial haploidentical or MUD allogeneic stem cell transplantation with CD34 enrichment and T-cell addback. This patient population historically has a risk of developing sinusoidal obstructive syndrome (SOS) and Defibrotide has demonstrated efficacy in treatment of SOS. The Funding Source is FDA OOPD.
Trial Details
NCT Number NCT02675959
Lead Sponsor New York Medical College
Collaborators: University of California, Los Angeles, Medical College of Wisconsin, Johns Hopkins University, Dana-Farber Cancer Institute, Children's Hospital Los Angeles, Children's Hospital Medical Center, Cincinnati, University of Florida
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov