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

University of Bologna

Status: Enrolling

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Other: Gut microbiome analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05725720

IG2022id27350

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years.
2. Patients affected by histologically confirmed DLBCL.
3. Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).
4. Patients must provide written informed consent.

Exclusion criteria

1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
2. Concurrent second malignancy.