An observational study in Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides and Cutaneous T-Cell Lymphoma/Sezary Syndrome, sponsored by Fondazione Italiana Linfomi - ETS. Recruiting at 18 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Fondazione Italiana Linfomi - ETS · Observational
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).
Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.
This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
337 studies on the registry are indexed under Lymphoma, T-Cell, Cutaneous; 61 are open to participants now.
This study's planned enrollment of 400 is above the median of 135 across 40 observational studies indexed under Lymphoma, T-Cell, Cutaneous.
Browse Lymphoma, T-Cell, Cutaneous studies →Fondazione Italiana Linfomi - ETS is the lead sponsor of 89 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in real life settings
Exclusion Criteria:
Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in a real life setting.
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Type of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Frequency of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).
Frequency of baseline characteristics.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).
Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Overall Survival of enrolled patients.
Overall Survival
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the safety of each different systemic treatments.
Frequency of adverse events collected with the clinical course.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Impact of new drugs (brentuximab vedotin and mogamulizumab).
Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Plan to share: Undecided
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Fondazione Italiana Linfomi - ETS