Cutaneous T Cell LymphomaFIL_MOGANCT06113081
Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
An observational study of Cutaneous T Cell Lymphoma and Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by Fondazione Italiana Linfomi - ETS at 21 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome
- How many people
- 100 participants
- Where
- 21 sitesItaly
- Study dates
- 6 Jun 2024to 11 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by relapsed/refractory Cutaneous T-cell Lymphoma who have received Mogamulizumab in real life settings
Who may be able to join
- 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.
Who cannot join
- Patients not meeting the above-mentioned inclusion criteria
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
Clinica di Ematologia - AOU Ospedali Riuniti delle Marche
Ancona
S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati
Avellino
Clinica Dermatologia - A.O.U. Policlinico Consorziale
Bari
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari
Istituto di Ematologia - Policlinico S.Orsola-Malpighi
Bologna
S.C. Ematologia - ASST Spedali Civili
Brescia
S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco
Cagliari
U.O.C. di Ematologia - A.O.U. Policlinico S. Marco
Catania
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Florence
S.C. Dermatologia - IRCCS Policlinico S. Martino
Genova
S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino
Genova
U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
Milan
Clinica Dermatologica - A.O.U. Luigi Vanvitelli
Naples
U.O.C. Dermatologia . A.O.U. di Padova
Padova
Divisione di Ematologia - IRCCS Policlinico San Matteo
Pavia
U.O. Ematologia - Ospedale Guglielmo da Saliceto
Piacenza
U.O.C. Ematologia - Policlinico Tor Vergata
Roma
UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano
Roma
U.O.C. Ematologia - A.O.U. Senese
Siena
S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
Torino
Verona - AOU Integrata di Verona - U.O. Ematologia
Verona, 37134
About this study
Official title: 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
Read the 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.
- Conditions
- Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome, Mogamulizumab, MAVORIC, Retrospective, Relapsed, Refractory
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled | Patients affected by relapsed/refractory Cutaneous T cell Lymphoma who have received Mogamulizumab in real life setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess Overall response rate lasting at least 4 months (ORR4)
Overall response lasting at least 4 months from response (CR+PR) to treatment with mogamulizumab
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary outcomes (6)
To assess Frequencies of baseline characteristic compared with the expected from MAVORIC study
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
Measured: 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
Evaluate the early and late activity of mogamulizumab
Measured: 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
To identify whether the presence of a B1 B2 score is associated with a higher response rate in the skin, compared to B0
Measured: 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
To investigate whether the presence of a cutaneous side effect is associated with a different clinical course and high response rate
Measured: 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)
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)
Measured: 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
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
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start6 Jun 2024
- Primary completion10 Oct 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Quaglino, MD, Principal investigator, SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113081
- Sponsor's protocol ID
- FIL_MOGA
- Acronym
- FIL_MOGA
- Status last verified
- May 2026
- First submitted
- 27 Oct 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma: a Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06113081
- Acronym / sponsor ID
- FIL_MOGA / FIL_MOGA
- Conditions
- Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome, Mogamulizumab, MAVORIC, Retrospective, Relapsed, Refractory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled | – | –Patients affected by relapsed/refractory Cutaneous T cell Lymphoma who have received Mogamulizumab in real life setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by relapsed/refractory Cutaneous T-cell Lymphoma who have received Mogamulizumab in real life settings
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not meeting the above-mentioned inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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 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)
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 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 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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Quaglino, MD principal investigator
SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous T Cell Lymphoma and Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by Fondazione Italiana Linfomi - ETS at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.