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NCT Number: NCT06588868

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.

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Key information

Conditions

Cutaneous T Cell Lymphoma Cutaneous T-Cell Lymphoma/Mycosis Fungoides Cutaneous T-Cell Lymphoma/Sezary Syndrome Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Sezary Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Ospedali Riuniti delle Marche - Clinica di Ematologia, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients not meeting the above-mentioned inclusion criteria.
  • Refuse to sign a written informed consent.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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)

    Frequency of baseline characteristics.

  2. 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)

    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.

  3. 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)

    Overall Survival

  4. 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)

    Frequency of adverse events collected with the clinical course.

  5. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Uffici Studi FIL

CONTACT

[email protected]

+390131033153

Uffici Studi FIL

CONTACT

[email protected]

+390599769913

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Collaborators

  • Takeda

Registry information

Official study title

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study

Acronym: FIL_CTCL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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