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Anaplastic Large Cell LymphomaFIL_BREALNCT07467317

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

An observational study of Anaplastic Large Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 19 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anaplastic Large Cell Lymphoma
How many people
100 participants
Where
19 sitesItaly
Study dates
Nov 2026to Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Uffici Studi FIL contact

+390131033153

startup@filinf.it

Uffici Studi FIL contact

+390599769913

gestionestudi@filinf.it

19 sites in 1 country

Italy19 sites

  • A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

    Avellino

    Sonya De Lorenzo, MD, sonya.delorenzo@tin.it

    Sonya De Lorenzo, MD

  • I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati

    Aviano

    Michele Spina, MD, mspina@cro.it

    Michele Spina, MD

  • I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia

    Bari

    Carla Minoia, MD, carla.minoia1@gmail.com

    Carla Minoia, MD

  • A.S.S.T Papa Giovanni XXIII - S.C. Ematologia

    Bergamo

    Giuseppe Gritti, MD, g.gritti@asst-pg23.it

    Giuseppe Gritti, MD

  • I.R.C.C.S. A.O.U. di Bologna Policlinico S. Orsola - U.O. Ematologia

    Bologna

    Cinzia Pellegrini, MD, cinzia.pellegrini5@unibo.it

    Cinzia Pellegrini, MD

  • I.R.C.C.S. Istituto di Candiolo - FPO

    Candiolo

    Francesca Bonello, MD, francesca.bonello@ircc.it

    Francesca Bonello, MD

  • A.S.S.T. Ovest Milanese Ospedale di Legnano - U.O.C. di Ematologia

    Legnano

    Silvia Franceschetti, MD, silvia.franceschetti@asst-ovestmi.it

    Silvia Franceschetti, MD

  • A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

    Milan

    Erika Meli, MD, erika.meli@ospedaleniguarda.it

    Erika Meli, MD

  • I.R.C.C.S. Istituto Europeo di Oncologia - U.O. Oncoematologia

    Milan

    Caterina Cristinelli, MD, caterina.cristinelli@ieo.it

    Caterina Cristinelli, MD

  • I.R.C.C.S. Ospedale San Raffaele - U.O. Ematologia e Trapianto di Midollo Osseo

    Milan

    Federico Erbella, MD, erbella.federico@hsr.it

    Federico Erbella, MD

  • A.S.L. di Pescara P.O. Santo Spirito - U.O.C. Ematologia

    Pescara

    Giuseppina Ricciuti, MD, giuseppina.ricciuti@asl.pe.it

    Giuseppina Ricciuti, MD

  • A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti

    Piacenza

    Annalisa Arcari, MD, a.arcari@ausl.pc.it

    Annalisa Arcari, MD

  • I.R.C.C.S. Fondazione Policlinico Universitario Gemelli - U.O.S.D. Malattie linfoproliferative extramidollari

    Roma

    Francesco D'Alò, MD, francesco.dalo@unicatt.it

    Francesco D'Alò, MD

  • IRCCS Humanitas Research Hospital - U.O. Ematologia

    Rozzano

    Filippo Bagnoli, MD, filippo.bagnoli@cancercenter.humanitas.it

    Filippo Bagnoli, MD

  • A.O. Ordine Mauriziano - S.C.D.U. Ematologia

    Torino

    Daniela Gottardi, MD, dgottardi@mauriziano.it

    Daniela Gottardi, MD

  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia

    Torino

    Barbara Botto, MD, bbotto@cittadellasalute.to.it

    Barbara Botto, MD

  • U.L.S.S. 2 Marca Trevigiana Osp. Ca' Foncello - U.O.C. Ematologia

    Treviso

    Elisabetta Scarpa, MD, elisabetta.scarpa@aulss2.veneto.it

    Elisabetta Scarpa, MD

  • A.S.S.T. Sette Laghi - S.C. Ematologia

    Varese

    Marta Coscia, MD, Marta.Coscia@asst-settelaghi.it

    Marta Coscia, MD

  • U.L.S.S. 8 Berica - U.O.C. Ematologia

    Vicenza

    Marcello Riva, MD, marcello.riva@aulss8.veneto.it

    Marcello Riva, MD

Other trials in Italy

About this study

Official title: 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.

Keywords
Anaplastic Large Cell Lymphoma, ALK, DUSP22, TP63, BV-CHP, Brentuximab vedotin, sALCL
Medical subject headings
Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07467317
Study groupRoleWhat they receive
Patients enrolledPatient affected by sALCL (ALK positive and ALK negative) that have received BV-CHP as front-line therapy in real life setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the progression free survival (PFS)

    Progression free survival (PFS) from the diagnosis of ALCL

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

Secondary outcomes (19)

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

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

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

  2. To evaluate the overall survival (OS)

    Overall survival (OS) from diagnosis of lymphoma

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

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

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

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

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

    PFS stratified according to interim PET result

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

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

    Rate of ORR and CR with and without ASCT consolidation

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

  6. To assess the incidence of early and late relapses

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

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

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

    Rate of CR and ORR after subsequent therapies

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

  8. To assess predictive factors of response rate

    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)

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

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

    OS stratified according to interim PET result

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

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

    OS stratified according to EOT PET result

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

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

    PFS stratified according to EOT PET result

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

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

    OS stratified according to baseline PET TMTV

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

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

    PFS stratified according to baseline PET TMTV

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

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

    OS stratified according to baseline PET TLG

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

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

    PFS stratified according to baseline PET TLG

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

  16. To assess predictive factors of Progression Free Survival

    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)

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

  17. To assess predictive factors of Overall Survival

    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)

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

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

    PFS stratified with and without ASCT consolidation

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

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

    OS stratified with and without ASCT consolidation

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07467317
Sponsor's protocol ID
FIL_BREAL
Acronym
FIL_BREAL
Status last verified
Oct 2026
First submitted
26 Feb 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anaplastic Large Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 19 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the progression free survival (PFS) (time frame: From the beginning to the end of the study (up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07467317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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