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

Fondazione Italiana Linfomi - ETS

Status

Completed

Conditions

Cutaneous T Cell Lymphoma

Cutaneous T-Cell Lymphoma/Sezary Syndrome

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Study type

Observational

Funder types

Other

Identifiers

NCT06113081

FIL_MOGA

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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