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NCT Number: NCT07467317

BV-CHP Real-life and Biological Evidences in Patients With sALCL

Systemic Anaplastic Large Cell Lymphomas (sALCL) are rare lymphomas for which the cooperation in the collection of biological and clinical data is necessary to improve knowledge on the disease. The addition of a targeted therapy to chemotherapy recently showed to be effective compared to standard chemotherapy. First-line therapy brentuximab vedotin-CHP for sALCL was recently approved in Italy following the published 5-year data from the ECHELON-2 study. Correlations with biological parameters are missing.

Within the framework of the FIL, Investigators will assess the clinical outcomes-specifically response rates, progression-free survival (PFS), safety-in a retrospective cohort of patients diagnosed with sALCL and treated frontline with BV-CHP in the real-life setting. These outcomes will be correlated with data derived from PET/CT imaging and lymph node biological samples.

Furthermore, Investigators will collect lymph node samples of patients diagnosed with sALCL and treated with BV-CHP at FIL Centers. The study will investigate the prognostic relevance of known molecular alterations (e.g., DUSP22, TP63). Through whole-exome sequencing and transcriptomic profiling, recurrent genetic alterations will be explored, as well as the cell of origin and the tumor microenvironment of sALCL, with particular attention to cell-to-cell interactions. A machine learning model will be validated to identify DUSP22 rearrangements from hematoxylin&eosin (H&E)-stained slides. Finally, integrated analysis of omics and clinical data using AI will aim to uncover biological signatures predictive of treatment response.

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Key information

Conditions

Anaplastic Large Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico, Avellino, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years;
  • Histological diagnosis of sALCL (ALK positive and ALK negative);
  • Have received BV-CHP as front-line therapy in real life setting;
  • Availability of histological material of initial ALCLs diagnosis: a FFPE block from an excisional/incisional biopsy must be provided for patient enrollment. FNAB and GNAB will not be considered for the study;
  • Signed written informed consent

Exclusion criteria

  • Histological diagnosis other than sALCL;
  • Front line treatment other than BV-CHP;
  • Patients treated with BV-CHP in the contest of a clinical trial;
  • Refuse to sign a written informed consent.

Treatment and study plan

Primary outcomes

  1. To evaluate the progression free survival (PFS)

    Time frame: From the beginning to the end of the study (up to 24 months)

    Progression free survival (PFS) from the diagnosis of ALCL

Secondary outcomes

  1. To evaluate overall response rate (metabolic CR+PR)

    Time frame: From the beginning to the end of the study (up to 24 months)

    Rate of overall response rate (ORR, CR+PR)

  2. To evaluate the overall survival (OS)

    Time frame: From the beginning to the end of the study (up to 24 months)

    Overall survival (OS) from diagnosis of lymphoma

  3. To evaluate safety profile of the BV-CHP regimen

    Time frame: From the beginning to the end of the study (up to 24 months)

    Incidence of any grade of adverse events (AEs) and of AEs with grade >2 according to CTCAE v5

  4. To assess the prognostic role of interim PET scan in term of Progression Free Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    PFS stratified according to interim PET result

  5. To explore the role of ASCT consolidation in term of overall response rate

    Time frame: From the beginning to the end of the study (up to 24 months)

    Rate of ORR and CR with and without ASCT consolidation

  6. To assess the incidence of early and late relapses

    Time frame: From the beginning to the end of the study (up to 24 months)

    Rate of POD24 (early and late first progression/relapse after induction treatment)

  7. To assess the response rate to subsequent therapies including BV-retreatment

    Time frame: From the beginning to the end of the study (up to 24 months)

    Rate of CR and ORR after subsequent therapies

  8. To assess predictive factors of response rate

    Time frame: From the beginning to the end of the study (up to 24 months)

    Investigate if one or more response rate predictive factors could be identify among clinical data, biological data (presence of ALK, DUSP22, TP63 alterations, mutational landscape, gene expression profile, immunological characteristics, tumor microenvironment features) and imaging data (PET scan results, baseline TMTV and TLG values)

  9. To assess the prognostic role of interim PET scan in term of Overall Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    OS stratified according to interim PET result

  10. To assess the prognostic role of end of treatment PET scan in term of Overall Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    OS stratified according to EOT PET result

  11. To assess the prognostic role of end of treatment PET scan in term of Progression Free Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    PFS stratified according to EOT PET result

  12. To assess the prognostic role of baseline Total Metabolic Tumor Volume in term of Overall Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    OS stratified according to baseline PET TMTV

  13. To assess the prognostic role of baseline Total Metabolic Tumor Volume in term of Progression Free Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    PFS stratified according to baseline PET TMTV

  14. To assess the prognostic role of baseline Total Lesion Glycolysis in term of Overall Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    OS stratified according to baseline PET TLG

  15. To assess the prognostic role of baseline Total Lesion Glycolysis in term of Progression Free Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    PFS stratified according to baseline PET TLG

  16. To assess predictive factors of Progression Free Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    Investigate if one or more PFS predictive factors could be identify among clinical data, biological data (presence of ALK, DUSP22, TP63 alterations, mutational landscape, gene expression profile, immunological characteristics, tumor microenvironment features) and imaging data (PET scan results, baseline TMTV and TLG values)

  17. To assess predictive factors of Overall Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    Investigate if one or more OS predictive factors could be identify among clinical data, biological data (presence of ALK, DUSP22, TP63 alterations, mutational landscape, gene expression profile, immunological characteristics, tumor microenvironment features) and imaging data (PET scan results, baseline TMTV and TLG values)

  18. To explore the role of ASCT consolidation in term of Progression Free Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    PFS stratified with and without ASCT consolidation

  19. To explore the role of ASCT consolidation in term of Overall Survival

    Time frame: From the beginning to the end of the study (up to 24 months)

    OS stratified with and without ASCT consolidation

Study contacts

Contact information is provided by the study sponsor or research team.

Uffici Studi FIL

CONTACT

[email protected]

+390131033153

Uffici Studi FIL

CONTACT

[email protected]

+390599769913

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study title

FIL_BREAL: BV-CHP Real-life and Biological Evidences in Patients With sALCL

Acronym: FIL_BREAL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Mar 30, 2026

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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