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Comparison of Point-of-care Produced CAR T-cell With Commercial CAR T-cells in Patients With R/R LBCL

Study acronym: HOVON161
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Dec 2025 → Jun 2027
See other at-risk trials from University Medical Center Groningen

Record History

  1. Primary completion pushed from Dec 2025 to Jun 2027 Enrollment closed, study ongoing · Final enrollment: 340 participants (planned 300) · Completion pushed from Dec 2027 to Sep 2028 · 4 more Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 340 participants (planned 300)
    • Completion pushed from Dec 2027 to Sep 2028
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints: details revised at 20 of 22 entries
    • Study description revised
    • Site details revised at 7 of 7 sites
  2. Eligibility criteria shortened, about 22 words Study description expanded, about 10 words · Site details revised at 6 of 7 sitesv2 Show 2 more changesShow less
    • Study description expanded, about 10 words
    • Site details revised at 6 of 7 sites

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R/R) DLBCL.
Trial Details
NCT Number NCT05641428
Lead Sponsor University Medical Center Groningen
Collaborators: Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions NHL, DLBCL - Diffuse Large B Cell Lymphoma
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov