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Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy

Study acronym: MicroCar
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 23% 90 → 69 participants
See other at-risk trials from University of Bologna

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment reduced: 90 → 69 participants
    • Site details revised
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2023 to Mar 23, 2023
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.
Trial Details
NCT Number NCT05725720
Lead Sponsor University of Bologna
Collaborators: Associazione Italiana per la Ricerca sul Cancro, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions
(from sponsor)		 Diffuse Large B Cell Lymphoma
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov