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

March 27, 2026 updated by: Fondazione Italiana Linfomi - ETS

FIL_BREAL: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Avellino, Italy
        • A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
        • Contact:
        • Principal Investigator:
          • Sonya De Lorenzo, MD
      • Aviano, Italy
        • I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
        • Contact:
        • Principal Investigator:
          • Michele Spina, MD
      • Bari, Italy
        • I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
        • Principal Investigator:
          • Carla Minoia, MD
        • Contact:
      • Bergamo, Italy
        • A.S.S.T Papa Giovanni XXIII - S.C. Ematologia
        • Principal Investigator:
          • Giuseppe Gritti, MD
        • Contact:
      • Bologna, Italy
        • I.R.C.C.S. A.O.U. di Bologna Policlinico S. Orsola - U.O. Ematologia
        • Contact:
        • Principal Investigator:
          • Cinzia Pellegrini, MD
      • Candiolo, Italy
        • I.R.C.C.S. Istituto di Candiolo - FPO
        • Contact:
        • Principal Investigator:
          • Francesca Bonello, MD
      • Legnano, Italy
        • A.S.S.T. Ovest Milanese Ospedale di Legnano - U.O.C. di Ematologia
        • Principal Investigator:
          • Silvia Franceschetti, MD
        • Contact:
      • Milan, Italy
        • A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Erika Meli, MD
      • Milan, Italy
        • I.R.C.C.S. Istituto Europeo di Oncologia - U.O. Oncoematologia
        • Contact:
        • Principal Investigator:
          • Caterina Cristinelli, MD
      • Milan, Italy
        • I.R.C.C.S. Ospedale San Raffaele - U.O. Ematologia e Trapianto di Midollo Osseo
        • Contact:
        • Principal Investigator:
          • Federico Erbella, MD
      • Pescara, Italy
        • A.S.L. di Pescara P.O. Santo Spirito - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Giuseppina Ricciuti, MD
      • Piacenza, Italy
        • A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti
        • Contact:
        • Principal Investigator:
          • Annalisa Arcari, MD
      • Roma, Italy
        • I.R.C.C.S. Fondazione Policlinico Universitario Gemelli - U.O.S.D. Malattie linfoproliferative extramidollari
        • Contact:
        • Principal Investigator:
          • Francesco D'Alò, MD
      • Rozzano, Italy
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
        • Principal Investigator:
          • Barbara Botto, MD
        • Contact:
      • Torino, Italy
        • A.O. Ordine Mauriziano - S.C.D.U. Ematologia
        • Contact:
        • Principal Investigator:
          • Daniela Gottardi, MD
      • Treviso, Italy
        • U.L.S.S. 2 Marca Trevigiana Osp. Ca' Foncello - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Elisabetta Scarpa, MD
      • Varese, Italy
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient affected by systemic Anaplastic Large Cell Lymphoma treated as front line therapy with BV-CHP in clinical practice

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients enrolled
Patient affected by sALCL (ALK positive and ALK negative) that have received BV-CHP as front-line therapy in real life setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the beginning to the end of the study (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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)
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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)
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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)
From the beginning to the end of the study (up to 24 months)
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)
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)
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
From the beginning to the end of the study (up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Carla Minoia, MD, Bari - I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_BREAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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