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

Sponsor

University of Bologna (Other)

Overall Status

Unknown status

CT.gov ID

NCT03797170

Collaborator

(none)

Enrollment

Locations

32.6

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma	Other: Gut microbiota samples

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 2, 2019

Anticipated Primary Completion Date :

Jul 20, 2020

Anticipated Study Completion Date :

Dec 20, 2021

Outcome Measures

Primary Outcome Measures

GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients) [18 months]
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.

Secondary Outcome Measures

Response to therapy [2 years]
Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative and all lymph nodes and nodal masses must have regressed on CT to normal size ( 1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.