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

NCT05725720 | Recruiting

• 1 other identifier: IG2022id27350
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Gut microbiome; CAR T-cell therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control.

  4 years

Interventions

Gut microbiome analysis OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 90 relapsed/refractory diffuse large B-cell lymphoma adult (≥18 years) patients undergoing CAR-T cell therapy will be enrolled over 3 years, treated and followed up with fecal sample collection until 18 months after CAR-T cell infusion.

You may qualify if:

• Age ≥18 years.
• Patients affected by histologically confirmed DLBCL.
• Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).
• Patients must provide written informed consent.

You may not qualify if:

• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
• Concurrent second malignancy.

Sponsors & Collaborators

• University of Bologna: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (1)

Institute Of Hematology "Seràgnoli"

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Hematology

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 13, 2023
• Study Start: March 23, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

IT (1)