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

NCT06113081 | Completed

• 1 other identifier: FIL_MOGA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 21

Brief 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

Conditions

Cutaneous T Cell Lymphoma; Cutaneous T-Cell Lymphoma/Sezary Syndrome; Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Keywords

Cutaneous T Cell Lymphoma; Mycosis Fungoides; Sezary Syndrome; Mogamulizumab; MAVORIC; Retrospective; Relapsed; Refractory

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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)

  The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)

Study Arms (1)

Patients enrolled

Patients affected by relapsed/refractory Cutaneous T cell Lymphoma who have received Mogamulizumab in real life setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by relapsed/refractory Cutaneous T-cell Lymphoma who have received Mogamulizumab in real life settings

You may qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (21)

Clinica di Ematologia - AOU Ospedali Riuniti delle Marche

Ancona, Italy

Location

S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati

Avellino, Italy

Location

Clinica Dermatologia - A.O.U. Policlinico Consorziale

Bari, Italy

Location

U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II

Bari, Italy

Location

Istituto di Ematologia - Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

S.C. Ematologia - ASST Spedali Civili

Brescia, Italy

Location

S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco

Cagliari, Italy

Location

U.O.C. di Ematologia - A.O.U. Policlinico S. Marco

Catania, Italy

Location

Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

S.C. Dermatologia - IRCCS Policlinico S. Martino

Genova, Italy

Location

S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino

Genova, Italy

Location

U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda

Milan, Italy

Location

Clinica Dermatologica - A.O.U. Luigi Vanvitelli

Naples, Italy

Location

U.O.C. Dermatologia . A.O.U. di Padova

Padua, Italy

Location

Divisione di Ematologia - IRCCS Policlinico San Matteo

Pavia, Italy

Location

U.O. Ematologia - Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

U.O.C. Ematologia - Policlinico Tor Vergata

Roma, Italy

Location

UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano

Roma, Italy

Location

U.O.C. Ematologia - A.O.U. Senese

Siena, Italy

Location

S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy

Location

Verona - AOU Integrata di Verona - U.O. Ematologia

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pietro Quaglino, MD

  SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: June 6, 2024
• Primary Completion: October 10, 2025
• Study Completion: November 11, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

IT (21)