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A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Feb 2025 to Sep 2028v15
  2. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 30 to confirmed 28 · Study sites: 18 to 16v14 Show 2 more changesShow less
    • Enrollment target: estimated 30 to confirmed 28
    • Study sites: 18 to 16
  3. Notable Trial status: Active, Not Recruiting to Recruiting Primary and study completion dates: Mar 2040 to Feb 2025 · Start date: Nov 9, 2016 to Mar 10, 2021 · Study sites: 16 to 18v13 Show 3 more changesShow less
    • Primary and study completion dates: Mar 2040 to Feb 2025
    • Start date: Nov 9, 2016 to Mar 10, 2021
    • Study sites: 16 to 18
  4. Minor Re-verified, no change to tracked fieldsv12
  5. Notable Enrollment target: 300 to 30 Trial status: Enrolling by Invitation to Active, Not Recruiting · Secondary endpoints: details revised at 1 of 6 entries · Study title revisedv11 Show 3 more changesShow less
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. Notable Primary endpoint revised Study sites: 21 to 16 · Interventions: UCART19/ALLO-501 follow-up (Biological) to UCART19 follow-up (Biological) · Eligibility criteria expanded, about 9 words · 2 morev10 Show 5 more changesShow less
    • Study sites: 21 to 16
    • Interventions: UCART19/ALLO-501 follow-up (Biological) to UCART19 follow-up (Biological)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 7 to 6
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study sites: 22 to 21v9
  3. Minor Study sites: 16 to 22v8
  4. Notable Enrollment target: 200 to 300 Primary endpoint revised · Study sites: 11 to 16 · Interventions: UCART19 follow-up (Biological) to UCART19/ALLO-501 follow-up (Biological) · 4 morev7 Show 7 more changesShow less
    • Primary endpoint revised
    • Study sites: 11 to 16
    • Interventions: UCART19 follow-up (Biological) to UCART19/ALLO-501 follow-up (Biological)
    • Eligibility criteria revised
    • Secondary endpoints: 5 to 7
    • Study title revised
    • Collaborators expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Notable Phase: Not applicable to Phase 1 Study sites: 10 to 11 · Interventions: UCART19 follow-up (Genetic) to UCART19 follow-up (Biological) · Secondary endpoints: details revised at 5 of 5 entriesv6 Show 3 more changesShow less
    • Study sites: 10 to 11
    • Interventions: UCART19 follow-up (Genetic) to UCART19 follow-up (Biological)
    • Secondary endpoints: details revised at 5 of 5 entries
  6. Minor Study sites: 7 to 10v5
  7. Minor Trial status: Recruiting to Enrolling by Invitation Site details revised at 7 of 7 sitesv4 Show 1 more changeShow less
    • Site details revised at 7 of 7 sites
  8. Minor Study sites: 1 to 7 Start date: Nov 2016 to Nov 9, 2016 · Eligibility criteria shortened, about 11 words · Secondary endpoints revised (5)v3 Show 3 more changesShow less
    • Start date: Nov 2016 to Nov 9, 2016
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  9. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Aug 2016 to Nov 2016 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: Aug 2016 to Nov 2016
    • Study sites: 0 to 1
  1. Minor 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 purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.
Trial Details
NCT Number NCT02735083
Lead Sponsor Institut de Recherches Internationales Servier
Collaborators: ADIR, a Servier Group company
Conditions Advanced Lymphoid Leukemia
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov