BV-CHP Real-life and Biological Evidences in Patients With sALCL
FIL_BREAL
FIL_BREAL: BV-CHP Real-life and Biological Evidences in Patients With sALCL
1 other identifier
observational
100
1 country
19
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2026
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
March 30, 2026
March 1, 2026
2 years
February 26, 2026
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the progression free survival (PFS)
Progression free survival (PFS) from the diagnosis of ALCL
From the beginning to the end of the study (up to 24 months)
Secondary Outcomes (19)
To evaluate overall response rate (metabolic CR+PR)
From the beginning to the end of the study (up to 24 months)
To evaluate the overall survival (OS)
From the beginning to the end of the study (up to 24 months)
To evaluate safety profile of the BV-CHP regimen
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
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
From the beginning to the end of the study (up to 24 months)
- +14 more secondary outcomes
Study Arms (1)
Patients enrolled
Patient affected by sALCL (ALK positive and ALK negative) that have received BV-CHP as front-line therapy in real life setting
Eligibility Criteria
Patient affected by systemic Anaplastic Large Cell Lymphoma treated as front line therapy with BV-CHP in clinical practice
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
Aviano, Italy
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari, Italy
A.S.S.T Papa Giovanni XXIII - S.C. Ematologia
Bergamo, Italy
I.R.C.C.S. A.O.U. di Bologna Policlinico S. Orsola - U.O. Ematologia
Bologna, Italy
I.R.C.C.S. Istituto di Candiolo - FPO
Candiolo, Italy
A.S.S.T. Ovest Milanese Ospedale di Legnano - U.O.C. di Ematologia
Legnano, Italy
A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan, Italy
I.R.C.C.S. Istituto Europeo di Oncologia - U.O. Oncoematologia
Milan, Italy
I.R.C.C.S. Ospedale San Raffaele - U.O. Ematologia e Trapianto di Midollo Osseo
Milan, Italy
A.S.L. di Pescara P.O. Santo Spirito - U.O.C. Ematologia
Pescara, Italy
A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti
Piacenza, Italy
I.R.C.C.S. Fondazione Policlinico Universitario Gemelli - U.O.S.D. Malattie linfoproliferative extramidollari
Roma, Italy
IRCCS Humanitas Research Hospital - U.O. Ematologia
Rozzano, Italy
A.O. Ordine Mauriziano - S.C.D.U. Ematologia
Torino, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
U.L.S.S. 2 Marca Trevigiana Osp. Ca' Foncello - U.O.C. Ematologia
Treviso, Italy
A.S.S.T. Sette Laghi - S.C. Ematologia
Varese, Italy
U.L.S.S. 8 Berica - U.O.C. Ematologia
Vicenza, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Minoia, MD
Bari - I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 12, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03