Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome
Conditions
Keywords
Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sézary Syndrome, Retrospective, Systemic therapy, Real world
Brief summary
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Detailed description
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.
Interventions
None listed
Sponsors
Takeda
Fondazione Italiana Linfomi - ETS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1. * Age ≥18 years. * Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023. * Availability of complete medical records in order to provide protocol required variables * Signed written informed consent.
Exclusion criteria
* Patients not meeting the above-mentioned inclusion criteria. * Refuse to sign a written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the different systemic treatment approaches in real life settings in patients with CTCL. | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | Type of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging). | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | Frequency of baseline characteristics. |
| Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb). | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 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. |
| Overall Survival of enrolled patients. | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | Overall Survival |
| Evaluate the safety of each different systemic treatments. | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | Frequency of adverse events collected with the clinical course. |
| Impact of new drugs (brentuximab vedotin and mogamulizumab). | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 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. |
Countries
Italy
Contacts
Primary ContactUffici Studi FIL
Backup ContactUffici Studi FIL
Outcome results
None listed