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

May 29, 2026 updated by: Fondazione Italiana Linfomi - ETS

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Clinica di Ematologia - AOU Ospedali Riuniti delle Marche
      • Avellino, Italy
        • S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati
      • Bari, Italy
        • Clinica Dermatologia - A.O.U. Policlinico Consorziale
      • Bari, Italy
        • U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
      • Bologna, Italy
        • Istituto di Ematologia - Policlinico S.Orsola-Malpighi
      • Brescia, Italy
        • S.C. Ematologia - ASST Spedali Civili
      • Cagliari, Italy
        • S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco
      • Catania, Italy
        • U.O.C. di Ematologia - A.O.U. Policlinico S. Marco
      • Florence, Italy
        • Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
      • Genova, Italy
        • S.C. Dermatologia - IRCCS Policlinico S. Martino
      • Genova, Italy
        • S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino
      • Milan, Italy
        • U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
      • Naples, Italy
        • Clinica Dermatologica - A.O.U. Luigi Vanvitelli
      • Padova, Italy
        • U.O.C. Dermatologia . A.O.U. di Padova
      • Pavia, Italy
        • Divisione di Ematologia - IRCCS Policlinico San Matteo
      • Piacenza, Italy
        • U.O. Ematologia - Ospedale Guglielmo da Saliceto
      • Roma, Italy
        • U.O.C. Ematologia - Policlinico Tor Vergata
      • Roma, Italy
        • UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano
      • Siena, Italy
        • U.O.C. Ematologia - A.O.U. Senese
      • Torino, Italy
        • S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
      • Verona, Italy, 37134
        • Verona - AOU Integrata di Verona - U.O. Ematologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients enrolled
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)
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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)
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Pietro Quaglino, MD, SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

November 11, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_MOGA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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