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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bologna

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

No treatment groups listed

Sponsors and collaborators

University of Bologna

Lead sponsor

Associazione Italiana per la Ricerca sul Cancro

Collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborator