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

NCT03797170 | Unknown

• 2 other identifiers: OncopassportRF-2016-02363730
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

RCHOP; first line; microbiota; response; disease control; therapy toxicity

Outcome Measures

Primary Outcomes (1)

• GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients)

  * dysbiosis index: the dysbiosis index relies on the calculation of the weighted ratio between health-promoting and disease-associated GM components * relative abundance of GM biomarkers of an eubiotic GM state: all GM dysbiotic states share a common feature, i.e. the depletion of strategic health-promoting GM components such as Faecalibacterium prausnitzii and Lachnospiraceae. Thus, a GM dysbiotic state is determined by the assessment of a reduction of the abundance of these GM biomarkers below the thresholds characteristic of an eubiotc GM state.

  18 months

Secondary Outcomes (1)

• Response to therapy

  2 years

Interventions

Gut microbiota samples OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by diffuse large B-cell lymphoma (DLBCL) undergoing therapy with front-line R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone).

You may qualify if:

• Age ≥18 years
• Patients affected by histologically confirmed diffuse large B-cell lymphoma
• Patients amenable for therapy with RCHOP (RCHOP is the standard first line therapy for DLBCL and it scheduled regardless of participation in present study).
• Patients must provide written informed consent.

You may not qualify if:

• Concomitant second malignancy, other than lymphoma.
• Previous anti-lymphoma therapy.
• Pregnancy or breastfeeding.
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (2)

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

Meldola, FC, Italy

Location

Institute Of Hematology "Seràgnoli"

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gut microbiota

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 Officials

• Pier Luigi L Zinzani, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, MD (Hematologist)

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 9, 2019
• Study Start: April 2, 2019
• Primary Completion: July 20, 2023
• Study Completion: December 20, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

IT (2)