RecruitingNCT05725720

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

Sponsor

University of Bologna

Enrollment

90 participants

Start Date

Mar 23, 2023

Study Type

OBSERVATIONAL

Conditions

Diffuse Large B Cell Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether the mix of bacteria in the gut (the microbiome) affects how well CAR-T cell therapy works for people with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL). CAR-T therapy uses a patient's own immune cells, re-engineered to fight cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with DLBCL confirmed by biopsy - You are scheduled to receive CAR-T cell therapy under an approved clinical indication - You can provide written informed consent **You may NOT be eligible if...** - You have another active serious illness - You have a second cancer at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERGut 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