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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Patients enrolled

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
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

Time frame
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

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

Other outcomes

Sponsors and contacts

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