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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi - ETS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings