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Not Yet Recruiting NCT05725720

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

Conditions: Diffuse Large B Cell Lymphoma

Sex: All
Ages: 18 Years – N/A
Enrollment: 90
Sponsor: University of Bologna

Location: Italy

Summary

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

Inclusion Criteria: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.Exclusion Criteria:Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.Concurrent second malignancy.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05725720). StuddyBuddy aggregates publicly available trial information.