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A Study of Participants With Cerebral Adrenoleukodystrophy (CALD) Treated With Elivaldogene Autotemcel

Study acronym: Stargazer
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 2 to 3v5
  2. Re-verified, no change to tracked fieldsv4
  3. Study sites: 5 to 2v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 4 to 5
    • Start date changed from estimate of Feb 15, 2024 to Mar 27, 2024
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 main aim of this study is to assess and describe the safety outcomes, including newly diagnosed malignancies, of patients with CALD treated with eli-cel in the post-marketing setting (tradename Skysona) and to describe major functional disability (MFD)-free survival over time in participants with more advanced early active CALD. All enrolled participants with CALD treated with eli-cel in the post-marketing setting will be followed in this study for 15 years. No investigational drug product will be administered in this study. This study will enroll 120 participants with CALD treated with eli-cel in the post-marketing setting. A subpopulation of 24 participants with more advanced early active CALD will be specifically enrolled as required by the US FDA as a condition of accelerated approval and will be considered as a separate cohort for effectiveness outcomes.
Trial Details
NCT Number NCT06224413
Lead Sponsor Genetix Biotherapeutics Inc.
Collaborators: Center for International Blood and Marrow Transplant Research
Conditions
(from sponsor)		 Cerebral Adrenoleukodystrophy (CALD)
Related terms Adrenoleukodystrophy
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov