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Emapalumab Prevention of CAR-T Cell Associated Toxicities

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 1, 2026 → Aug 1, 2027
See other at-risk trials from Marcela V. Maus, M.D.,Ph.D.

Record History

  1. Primary completion pushed from Aug 1, 2026 to Aug 1, 2027 Completion pushed from Aug 1, 2027 to Aug 1, 2028 · Interventions modified · Trial arms changed: 1 → 4 · 3 more Show 6 more changesShow less
    • Completion pushed from Aug 1, 2027 to Aug 1, 2028
    • Interventions modified
    • Trial arms changed: 1 → 4
    • Eligibility criteria shortened, about 50 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 8 words
  2. Site contacts updated at 1 of 2 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2024 to Sep 18, 2024 · Site details revised at 2 of 2 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2024 to Sep 18, 2024
    • Site details revised at 2 of 2 sites
  4. Study Status, Study Description, Eligibilityv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL). The research study involves the following study interventions: * Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy) * Axicabtagene Ciloleucel or Lisocabtagene Maraleucel * Emapalumab
Trial Details
NCT Number NCT06550141
Lead Sponsor Marcela V. Maus, M.D.,Ph.D.
Collaborators: Swedish Orphan Biovitrum
Conditions Large B-cell Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov