Molecular Characterization and Outcomes of Aggressive B-Cell Lymphomas.

NCT07181785 | Completed

• 1 other identifier: CHARTHER
• Study Type: observational
• Target: 555
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. If this evaluation will be confirmed as a reliable method to reclassify in different groups the evaluated tumors, it can be subsequently routinely apply to indicate the best treatment approaches in this high-risk setting of patients with a significant impact on patients' morbidity and mortality, and also on the health system and related costs.

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival (OS) is time from the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first.

  From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months

Secondary Outcomes (6)

• Progression-free Survival (PFS)

  From the first day of treatment until relapse, progression, death , or last follow-up, whichever occurs first, assessed up to 60 months

• Overall Response Rate

  From the first day of treatment until the date of first documented response assessment, typically within 6 months of treatment initiation

• Duration of response (DOR; partial response [PR] + complete remission [CR])

  From the date of first documented response (CR or PR) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months

• Relapse rates

  From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months

• Relapse Pattern

  From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months

Study Arms (1)

Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphoma.

Histologically-confirmed diagnosis of LBCL (i.e., DLBCL, HGBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL), or aggressive B-cell lymphomas with blastoid morphology (excluding blastoid variant of mantle cell lymphoma and lymphoblastic lymphoma) * Histopathological diagnosis performed between 2000 and 2019. * HIV sero-negativity * Age ≥18 * Treatment with R-CHOP or other intensified polychemotherapy regimen * Availability of adequate histopathological samples at diagnosis for FISH analysis * Availability of clinical records and outcomes data

Combination Product: Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy

Interventions

Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy COMBINATION_PRODUCT

Anthracycline-based combinations followed or not by involved-field radiotherapy

Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphoma.

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

Adult subjects (\> 18 years old) of any age and gender affected by large B-cell lymphomas

You may not qualify if:

• Histologic diagnosis other than DLBCL or unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL

Sponsors & Collaborators

• Andrés José Maria Ferreri: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Italy

Location

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: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD & Prof.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 18, 2025
• Study Start: July 12, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

IT (1)