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

NCT ID: NCT06113081

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-06

Study Completion Date

2025-11-11

Brief Summary

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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

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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.

Conditions

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

Keywords

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Cutaneous T Cell Lymphoma Mycosis Fungoides Sezary Syndrome Mogamulizumab MAVORIC Retrospective Relapsed Refractory

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients enrolled

Patients affected by relapsed/refractory Cutaneous T cell Lymphoma who have received Mogamulizumab in real life setting

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pietro Quaglino, MD

Role: PRINCIPAL_INVESTIGATOR

SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino

Locations

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Clinica di Ematologia - AOU Ospedali Riuniti delle Marche

Ancona, , Italy

Site Status

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

Avellino, , Italy

Site Status

Clinica Dermatologia - A.O.U. Policlinico Consorziale

Bari, , Italy

Site Status

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

Bari, , Italy

Site Status

Istituto di Ematologia - Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status

S.C. Ematologia - ASST Spedali Civili

Brescia, , Italy

Site Status

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

Cagliari, , Italy

Site Status

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

Catania, , Italy

Site Status

Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status

S.C. Dermatologia - IRCCS Policlinico S. Martino

Genova, , Italy

Site Status

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

Genova, , Italy

Site Status

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

Milan, , Italy

Site Status

Clinica Dermatologica - A.O.U. Luigi Vanvitelli

Napoli, , Italy

Site Status

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

Padua, , Italy

Site Status

Divisione di Ematologia - IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

U.O. Ematologia - Ospedale Guglielmo da Saliceto

Piacenza, , Italy

Site Status

U.O.C. Ematologia - Policlinico Tor Vergata

Roma, , Italy

Site Status

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

Roma, , Italy

Site Status

U.O.C. Ematologia - A.O.U. Senese

Siena, , Italy

Site Status

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

Torino, , Italy

Site Status

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

Verona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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FIL_MOGA

Identifier Type: -

Identifier Source: org_study_id