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Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 1, 2039 → Dec 1, 2041
Primary endpoints added 1 → 5 primary endpoints
See other at-risk trials from Miltenyi Biomedicine GmbH

Record History

  1. Primary and study completion pushed from Dec 1, 2039 to Dec 1, 2041 Primary endpoint(s) modified · Trial sites expanded: 5 → 11 locations · Secondary endpoints: 4 to 6 · 1 morev5 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites expanded: 5 → 11 locations
    • Secondary endpoints: 4 to 6
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Site details revised at 5 of 5 sitesv4 Show 1 more changeShow less
    • Site details revised at 5 of 5 sites
  3. Start date: Feb 26, 2024 to May 15, 2024 Site contacts updated at 2 of 5 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 2 of 5 sites
  4. Start date: Nov 20, 2023 to Feb 26, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Trial Details
NCT Number NCT06116110
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions Non Hodgkin Lymphoma, Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma, Central Nervous System Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL)
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov