An observational study in Anaplastic Large Cell Lymphoma, sponsored by Fondazione Italiana Linfomi - ETS. Not yet recruiting at 19 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Fondazione Italiana Linfomi - ETS · Observational
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.
397 studies on the registry are indexed under Lymphoma, Large-Cell, Anaplastic; 26 are open to participants now.
This study's planned enrollment of 100 is close to the median of 98 across 26 observational studies indexed under Lymphoma, Large-Cell, Anaplastic.
Browse Lymphoma, Large-Cell, Anaplastic studies →Fondazione Italiana Linfomi - ETS is the lead sponsor of 91 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient affected by systemic Anaplastic Large Cell Lymphoma treated as front line therapy with BV-CHP in clinical practice
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient affected by sALCL (ALK positive and ALK negative) that have received BV-CHP as front-line therapy in real life setting
To evaluate the progression free survival (PFS)
Progression free survival (PFS) from the diagnosis of ALCL
Time frame: From the beginning to the end of the study (up to 24 months)
To evaluate overall response rate (metabolic CR+PR)
Rate of overall response rate (ORR, CR+PR)
Time frame: From the beginning to the end of the study (up to 24 months)
To evaluate the overall survival (OS)
Overall survival (OS) from diagnosis of lymphoma
Time frame: From the beginning to the end of the study (up to 24 months)
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
Time frame: 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
PFS stratified according to interim PET result
Time frame: 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
Rate of ORR and CR with and without ASCT consolidation
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the incidence of early and late relapses
Rate of POD24 (early and late first progression/relapse after induction treatment)
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the response rate to subsequent therapies including BV-retreatment
Rate of CR and ORR after subsequent therapies
Time frame: From the beginning to the end of the study (up to 24 months)
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)
Time frame: 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
OS stratified according to interim PET result
Time frame: 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
OS stratified according to EOT PET result
Time frame: 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
PFS stratified according to EOT PET result
Time frame: 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
OS stratified according to baseline PET TMTV
Time frame: 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
PFS stratified according to baseline PET TMTV
Time frame: 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
OS stratified according to baseline PET TLG
Time frame: 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
PFS stratified according to baseline PET TLG
Time frame: From the beginning to the end of the study (up to 24 months)
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)
Time frame: From the beginning to the end of the study (up to 24 months)
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)
Time frame: 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
PFS stratified with and without ASCT consolidation
Time frame: 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
OS stratified with and without ASCT consolidation
Time frame: From the beginning to the end of the study (up to 24 months)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Lymphoma, Large-Cell, Anaplastic →
Fondazione Italiana Linfomi - ETS