Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to describe the clinical activity and safety profile of mogamulizumab at standard dose in the treatment of CTCL patients in real world setting

Detailed Description
-----------------
Mogamulizumab (anti-CCR4) has been recently approved and reimbursed in Italy for the treatment of Cutaneous T-cell lymphoma (CTCL) after 1 previous systemic treatment based on the favourable results of the MAVORIC clinical trial. To date, no real-world data on significant series of patients treated routinely with mogamulizumab in clinical practice are available. As real-life data are essential to confirm the preliminary evidence displayed in phase III trials, this study aims at describing the clinical activity and safety profile of mogamulizumab at standard dose in the treatment of CTCL patients in real world settings.

Official Title
-----------------
Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma: a Multicenter Observational Study

Conditions
-----------------
Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria (Trautinger et al, Eur J Cancer, 2017) Age ≥18 years Have failed at least one previous line of systemic therapy Have received mogamulizumab in real life setting after the approval and reimbursement of the drug from the National Health System in December 2020 Have received first dose of mogamulizumab between 01/01/2021 and 31/01/2023 Have received mogamulizumab at the standard approved dose (1.0 mg/kg intravenously on days 1, 8, 15 and 22 of the first cycle and on days 1 and 15 of subsequent cycles) Availability of complete medical records. Exclusion Criteria: • Patients not meeting the above-mentioned inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients enrolled<br>Patients affected by relapsed/refractory Cutaneous T cell Lymphoma who have received Mogamulizumab in real life setting | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess Overall response rate lasting at least 4 months (ORR4) | Overall response lasting at least 4 months from response (CR+PR) to treatment with mogamulizumab | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess Frequencies of baseline characteristic compared with the expected from MAVORIC study | To identify whether real life patients show baseline characteristics (i.e., CTCL subtype, cutaneous and blood involvement, staging) in line with the population enrolled in the MAVORIC trial | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 
| To assess Overall response rate (ORR) at 1 month, ORR at 4 months and best ORR obtained from beginning of treatment with Mogamulizumab | Evaluate the early and late activity of mogamulizumab | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 
| To assess Logistic regression of ORR4 with peripheral blood involvement score | To identify whether the presence of a B1 B2 score is associated with a higher response rate in the skin, compared to B0 | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 
| To assess Frequencies of adverse events collected with the clinical course | To investigate whether the presence of a cutaneous side effect is associated with a different clinical course and high response rate | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 
| To assess Progression Free Survival (PFS), Overall Survival (OS), Time to Next Treatment (TTNT) | To investigate the overall efficacy of treatment. Time to event functions will be stratified according to the disease subtype (Mycosis fungoides/Sézary syndrome), stage (early vs advanced), number of previous treatment lines (1 or more than) | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 
| To assess Frequencies of patients who receive mogamulizumab as bridge to allotransplant, as well as disease features of these patients and type of response to transplant | To evaluate the number and related disease features of patients who receive mogamulizumab as bridge to allotransplant, as well as the type of response to transplant in these patients | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome, Mogamulizumab, MAVORIC, Retrospective, Relapsed, Refractory