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

Last updated: December 19, 2024
Sponsor: Fondazione Italiana Linfomi - ETS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cutaneous T-cell Lymphoma

Lymphoproliferative Disorders

Lymphoma

Treatment

N/A

Clinical Study ID

NCT06113081
FIL_MOGA
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria (Trautingeret 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 andreimbursement 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 intravenouslyon days 1, 8, 15 and 22 of the first cycle and on days 1 and 15 of subsequentcycles)

  • Availability of complete medical records.

Exclusion

Exclusion Criteria:

• Patients not meeting the above-mentioned inclusion criteria

Study Design

Total Participants: 150
Study Start date:
June 06, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Clinica di Ematologia - AOU Ospedali Riuniti delle Marche

    Ancona,
    Italy

    Active - Recruiting

  • S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati

    Avellino,
    Italy

    Active - Recruiting

  • Clinica Dermatologia - A.O.U. Policlinico Consorziale

    Bari,
    Italy

    Site Not Available

  • U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II

    Bari,
    Italy

    Site Not Available

  • Istituto di Ematologia - Policlinico S.Orsola-Malpighi

    Bologna,
    Italy

    Active - Recruiting

  • S.C. Ematologia - ASST Spedali Civili

    Brescia,
    Italy

    Active - Recruiting

  • S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco

    Cagliari,
    Italy

    Site Not Available

  • U.O.C. di Ematologia - A.O.U. Policlinico S. Marco

    Catania,
    Italy

    Site Not Available

  • Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi

    Firenze,
    Italy

    Active - Recruiting

  • S.C. Dermatologia - IRCCS Policlinico S. Martino

    Genova,
    Italy

    Active - Recruiting

  • S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino

    Genova,
    Italy

    Site Not Available

  • U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda

    Milano,
    Italy

    Active - Recruiting

  • Clinica Dermatologica - A.O.U. Luigi Vanvitelli

    Napoli,
    Italy

    Site Not Available

  • U.O.C. Dermatologia . A.O.U. di Padova

    Padova,
    Italy

    Site Not Available

  • Divisione di Ematologia - IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Site Not Available

  • U.O. Ematologia - Ospedale Guglielmo da Saliceto

    Piacenza,
    Italy

    Active - Recruiting

  • U.O.C. Ematologia - Policlinico Tor Vergata

    Roma,
    Italy

    Site Not Available

  • UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano

    Roma,
    Italy

    Active - Recruiting

  • U.O.C. Ematologia - A.O.U. Senese

    Siena,
    Italy

    Site Not Available

  • S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino

    Torino,
    Italy

    Active - Recruiting

  • Verona - AOU Integrata di Verona - U.O. Ematologia

    Verona, 37134
    Italy

    Active - Recruiting

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