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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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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.

Study details

Diffuse Large B Cell Lymphoma

NCT05725720

University of Bologna

25 January 2024

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