Investigating the gut microbiome's impact on lymphoma treatment outcomes
Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy
This study is trying to see how the bacteria in the gut might affect how well CAR-T cell therapy works for adults with a type of lymphoma called diffuse large B-cell lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bologna Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05725720 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between the gut microbiome and the effectiveness of CAR-T cell therapy in patients with diffuse large B-cell lymphoma (DLBCL). It will analyze the gut microbiome profiles of patients undergoing CAR-T cell therapy to determine how these profiles may influence treatment responses and associated toxicities. The study will include adult patients with histologically confirmed DLBCL who are eligible for CAR-T cell therapy, focusing on the diversity and composition of their gut microbiomes. By understanding these interactions, the study seeks to identify potential prognostic factors that could improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed diffuse large B-cell lymphoma who are eligible for CAR-T cell therapy.
Not a fit: Patients with significant uncontrolled concomitant diseases or concurrent second malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that enhance the effectiveness of CAR-T cell therapy for lymphoma patients.
How similar studies have performed: While the role of the gut microbiome in cancer treatment is an emerging field, this specific investigation into its impact on CAR-T cell therapy outcomes in lymphoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna
- Institute Of Hematology "Seràgnoli" — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.