Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma

NCT ID: NCT03797170

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2023-12-20

Brief Summary

In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Gut microbiota samples

Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Patients affected by histologically confirmed diffuse large B-cell lymphoma

3. Patients amenable for therapy with RCHOP (RCHOP is the standard first line therapy for DLBCL and it scheduled regardless of participation in present study).

4. Patients must provide written informed consent.

Exclusion Criteria

1. Concomitant second malignancy, other than lymphoma.

2. Previous anti-lymphoma therapy.

3. Pregnancy or breastfeeding.

4. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Pier Luigi Zinzani

Full Professor, MD (Hematologist)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pier Luigi L Zinzani, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology "L. e A. Seràgnoli", University of Bologna

Locations

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, FC, Italy

Institute Of Hematology "Seràgnoli"

Bologna, , Italy

Countries

Italy

Other Identifiers

RF-2016-02363730

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Oncopassport

Identifier Type: -

Identifier Source: org_study_id