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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-23

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Gut microbiome analysis

Characterization of the compositional and functional modifications of gut microbiome in patients affected by lymphoma undergoing therapy with CAR-T cells from baseline until the restaging after 18 months from the CAR-T cell infusion

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No