About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years.
Patients affected by histologically confirmed DLBCL.
Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).
Patients must provide written informed consent.
Disqualifiers
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
Concurrent second malignancy.
Trial design
Treatments tested in this trial
- Gut microbiome analysis
Treatment groups
Sponsors and collaborators
University of Bologna
Lead sponsor
Associazione Italiana per la Ricerca sul Cancro
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator