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Completed

NCT Number: NCT07181785

Molecular Characterization and Outcomes of Aggressive B-Cell Lymphomas.

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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Hospital

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Exclusion criteria

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

Treatment and study plan

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

Combination Product

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

Primary outcomes

  1. Overall Survival (OS)

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

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

Secondary outcomes

  1. Progression-free Survival (PFS)

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

    Progression-Free Survival (PFS) is the length of time during and after a disease treatment that a patient lives without the disease worsening or progressing

  2. Overall Response Rate

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

    the Overall Response Rate (ORR) measures the percentage of patients whose disease shows a reduction in size or is eliminated after a specific treatment. It includes patients who achieve either a Complete Response (CR), where all signs of the lymphoma disappear, or a Partial Response (PR), where there is a significant reduction in tumor burden but some signs of the disease remain

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

    Time frame: 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

    Time from the date of first documented response (complete or partial) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first.

  4. Relapse rates

    Time frame: 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

    Proportion of patients who experience disease relapse after achieving a complete or partial response.

  5. Relapse Pattern

    Time frame: 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

    Description of the type and location of disease relapse, including nodal vs extranodal and local vs systemic recurrence

  6. Incidence of chromosomal rearrangements involving MYC gene and BCL2 gene (so called "double hit lymphoma", representing 60% of HGBL) and/or BCL6 (also called "triple hit lymphoma", representing 20% of HG in Large B-cell Lymphomas.

    Time frame: At the time of pathologic diagnosis (baseline)

    Proportion of patients with documented genetic rearrangements of MYC, BCL2, or BCL6 detected at the time of pathologic diagnosis.

Sponsors and collaborators

Lead sponsor

Andrés José Maria Ferreri

Other

Registry information

Official study title

Single-center, Retrospective Study Aimed to Perform a Molecular Characterization of Aggressive B-cell Lymphomas (Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma With MYC and BCL2 and/or BCL6 Translocations, High-grade B-cell Lymphoma Not Otherwise Specified) and to Observe the Clinical Patients' Outcomes According to the 2017 WHO Classification

Acronym: CHARTHER

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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