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NCT Number: NCT06113081

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

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

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Key information

Conditions

Cutaneous T Cell Lymphoma Cutaneous T-Cell Lymphoma/Mycosis Fungoides Cutaneous T-Cell Lymphoma/Sezary Syndrome Disease Attributes 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 Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Sezary Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

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 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study title

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

Acronym: FIL_MOGA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2023
Registry last updated
Jun 1, 2026

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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