Cutaneous T Cell LymphomaFIL_CTCLNCT06588868
Systemic Therapies 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 18 sites in Italy.
Trial summary
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma 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
- 400 participants
- Where
- 18 sitesItaly
- Study dates
- 27 Feb 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in real life settings
Who may be able to join
- Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.
- Age ≥18 years.
- Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.
- Availability of complete medical records in order to provide protocol required variables
- Signed written informed consent.
Who cannot join
- Patients not meeting the above-mentioned inclusion criteria.
- Refuse to sign a written informed consent.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Italy18 sites, 18 recruiting
- Recruiting
AOU Ospedali Riuniti delle Marche - Clinica di Ematologia
Ancona
Serena Rupoli, MD, +390715964771, serena.rupoli@ospedaliriuniti.marche.it
Serena Rupoli, MD
- Recruiting
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari
Giacomo Loseto, MD, +390805555415, loseto.giacomo@gmail.com
Giacomo Loseto, MD
- Not yet recruiting
U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale
Bari
Raffaele Filotico, MD, raffaele.filotico@uniba.it
Raffaele Filotico, MD
- Recruiting
Policlinico S.Orsola-Malpighi - Istituto di Ematologia
Bologna
Pier Luigi Zinzani, MD, +390512144042, pierluigi.zinzani@unibo.it
Pier Luigi Zinzani, MD
- Not yet recruiting
ASST Spedali Civili di Brescia - S.C. Ematologia
Brescia
Alessandra Tucci, MD, +390303995438, alessandra.tucci@asst-spedalicivili.it
- Not yet recruiting
A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO
Cagliari
Daniela Dessi, MD, +3907052965371, daniela.dessi@aob.it
Daniela Dessi, MD
- Not yet recruiting
A.O.U. Policlinico S. Marco - U.O.C. di Ematologia
Catania
Amalia Figuera, MD, +390957436155, amaliafiguera@gmail.com
Amalia Figuera, MD
- Recruiting
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Florence
Benedetta Sordi, MD, benedetta.sordi@unifi.it
Benedetta Sordi, MD
- Recruiting
S.C. Dermatologia - E.O. Galliera
Genova
Cesare Massone, MD, cesare.massone@galliera.it
Cesare Massone, MD
- Not yet recruiting
Oncoematologia - ASST Fatebenefratelli - Sacco
Milan
Francesco Onida, MD, francesco.onida@asst-fbf-sacco.it
Francesco Onida, MD
- Recruiting
U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
Milan
Silvia Alberti Violetti, MD, silvia.alberti@unimi.it
Silvia Alberti Violetti, MD
- Not yet recruiting
U.O.C. Clinica Dermatologica - A.O.U. di Padova
Padova
Mauro Salvatore Alaibac, MD, mauro.alaibac@unipd.it
Mauro Salvatore Ailaibac, MD
- Not yet recruiting
U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo
Pavia
Luca Arcaini, MD, luca.arcaini@unipv.it
Luca Arcaini, MD
- Recruiting
IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare
Roma
Miriam Teoli, MD, +390652662825, miriam.teoli@ifo.it
Miriam Teoli, MD
- Not yet recruiting
Skin Cancer Center - IRCCS Istituto Dermopatico dell'Immacolata
Roma
Maria Cantonetti, MD, m.cantonetti@idi.it
Maria Cantonetti, MD
- Not yet recruiting
U.O.C. Dermatologia - A.O.U. Senese
Siena
Elisa Cinotti, MD, elisa.cinotti@unisi.it
Elisa Cinotti, MD
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino - S.C. Dermatologia U
Torino
Pietro Quaglino, MD, +390116335843, pietro.quaglino@unito.it
Pietro Quaglino, MD
- Recruiting
A.O.U.I. di Verona - U.O.C. Ematologia
Verona
Andrea Bernardelli, MD, +390458124797, andrea.bernardelli@aovr.veneto.it
Andrea Bernardelli, MD
About this study
Official title: Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Read the detailed description
The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).
Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.
This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
- Conditions
- Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sézary Syndrome, Retrospective, Systemic therapy, Real world
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
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 Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in a real life setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Type of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Frequency of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary outcomes (5)
To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).
Frequency of baseline characteristics.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).
Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Overall Survival of enrolled patients.
Overall Survival
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the safety of each different systemic treatments.
Frequency of adverse events collected with the clinical course.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Impact of new drugs (brentuximab vedotin and mogamulizumab).
Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.
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 posted19 Sep 2024
- Study start27 Feb 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- 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
- NCT06588868
- Sponsor's protocol ID
- FIL_CTCL
- Acronym
- FIL_CTCL
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06588868
- Acronym / sponsor ID
- FIL_CTCL / FIL_CTCL
- Conditions
- Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sézary Syndrome, Retrospective, Systemic therapy, Real world
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Detailed description
The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).
Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.
This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled | – | –Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in a 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 Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in real life settings
Key inclusion criteria (5 listed)
- Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.
- Age ≥18 years.
- Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.
- Availability of complete medical records in order to provide protocol required variables
- Signed written informed consent.
Key exclusion criteria (2 listed)
- Patients not meeting the above-mentioned inclusion criteria.
- Refuse to sign a written informed consent.
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 evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Type of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Frequency of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment
5 secondary outcomes
To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Overall Survival of enrolled patients.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the safety of each different systemic treatments.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Impact of new drugs (brentuximab vedotin and mogamulizumab).
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cutaneous T Cell Lymphoma
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Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
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Extracorporeal Photopheresis in Sezary Syndrome
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RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
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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.
Pietro Quaglino, MD principal investigator
SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
18 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 18 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL. (time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)). The study lists 3 primary outcomes in all. 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 2 Dec 2025.