Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02698579 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 13 sitesv23
  2. Re-verified, no change to tracked fieldsv22
  3. Interventions: Lenti-D Drug Product (Genetic) to No interventional drug product utilized in this follow-up study (Genetic)
    • Secondary endpoints: details revised at 1 of 3 entries
    v21
  4. Primary and study completion dates: May 2037 to Aug 2038v20
  5. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 67 to confirmed 64
    • Study sites: 11 to 13
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Primary endpoints: 9 to 6v18 Show 4 more changesShow less
    • Enrollment target: 60 to 67
    • Interventions: Lenti-D (Genetic) to Lenti-D Drug Product (Genetic)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints revised (3)
  2. Study sites: 10 to 11v17
  3. Study sites revised (10)v16
  4. Study sites: 9 to 10v15
  5. Re-verified, no change to tracked fieldsv14
  6. Study sites: 8 to 9v13
  7. Primary endpoints revised (9)v12 Show 6 more changesShow less
    • Enrollment target: 50 to 60
    • Start date: Jan 2016 to Jan 22, 2016
    • Interventions: Lenti-D; elivaldogene autotemcel (Drug) to Lenti-D (Genetic)
    • Eligibility criteria revised
    • Secondary endpoints revised (3)
    • Study title revised
  8. Primary and study completion dates: Mar 2036 to May 2037
    • Study sites: 9 to 8
    • Interventions: Safety and efficacy assessments (Other) to Lenti-D; elivaldogene autotemcel (Drug)
    v11
  9. Re-verified, no change to tracked fieldsv10
  10. Primary endpoints: 8 to 9v9
  11. Study sites: 8 to 9v8
  12. Study sites: 7 to 8v7
  13. Enrollment target: 25 to 50v6 Show 5 more changesShow less
    • Primary and study completion dates: Nov 2033 to Mar 2036
    • Primary endpoints: 9 to 8
    • Study sites: 6 to 7
    • Eligibility criteria shortened, about 50 words
    • Secondary endpoints revised (3)
  14. Eligibility criteria revisedv5
  15. Primary endpoints: 7 to 9v4 Show 4 more changesShow less
    • Enrollment target: 17 to 25
    • Study sites: 4 to 6
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 5 to 3
  16. Study sites: 3 to 4v3
  17. Study sites: 1 to 3
    • Secondary endpoints revised (5)
    • Study title shortened, about 1 word
    v2
  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 multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product (eli-cel) in a parent clinical study (Study ALD-102 or Study ALD-104). After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.
Trial Details
NCT Number NCT02698579
Lead Sponsor Genetix Biotherapeutics Inc.
Conditions
(from sponsor)		 Cerebral Adrenoleukodystrophy (CALD), Adrenoleukodystrophy (ALD), X-Linked Adrenoleukodystrophy (X-ALD)
Related terms Adrenoleukodystrophy
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov