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

Diffuse Large B Cell Lymphoma Clinical Trial

— MicroCar  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725720
• Other study ID #: IG2022id27350
• Status: Recruiting
• Start date: March 23, 2023
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2027
• Est. primary completion date: July 2027
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Institute Of Hematology "Seràgnoli"	Bologna

Sponsors (3)

Lead Sponsor	Collaborator
University of Bologna	Associazione Italiana per la Ricerca sul Cancro, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of GM heterogeneity (taxa) in diffuse large B-cell lymphoma patients undergoing CAR-T cell therapy.	Characterization of the compositional and functional modifications of GM 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. GM profiling will be achieved by next-generation sequencing approaches, including 16S rRNA gene-based sequencing for diversity and compositional structure, and shotgun metagenomics for species-level and functional insights, including information on eukaryotes and viruses.	24 months
Secondary	Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control.	Define novel GM signatures that relate to more favorable response to the CAR-T treatment and/or reducing the occurrence of side effects.	4 years