Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
- Conditions
- Cutaneous T-Cell Lymphoma/Mycosis FungoidesCutaneous T Cell LymphomaCutaneous T-Cell Lymphoma/Sezary Syndrome
- Registration Number
- NCT06113081
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
• Patients not meeting the above-mentioned inclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess Overall response rate lasting at least 4 months (ORR4) 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 Outcome Measures
Name Time Method 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 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
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) Evaluate the early and late activity of mogamulizumab
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 identify whether the presence of a B1 B2 score is associated with a higher response rate in the skin, compared to B0
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 investigate whether the presence of a cutaneous side effect is associated with a different clinical course and high response rate
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) 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)
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 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
Trial Locations
- Locations (21)
U.O.C. di Ematologia - A.O.U. Policlinico S. Marco
🇮🇹Catania, Italy
Clinica di Ematologia - AOU Ospedali Riuniti delle Marche
🇮🇹Ancona, Italy
S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati
🇮🇹Avellino, Italy
Clinica Dermatologia - A.O.U. Policlinico Consorziale
🇮🇹Bari, Italy
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Istituto di Ematologia - Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
S.C. Ematologia - ASST Spedali Civili
🇮🇹Brescia, Italy
S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco
🇮🇹Cagliari, Italy
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
S.C. Dermatologia - IRCCS Policlinico S. Martino
🇮🇹Genova, Italy
S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino
🇮🇹Genova, Italy
U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
🇮🇹Milano, Italy
Clinica Dermatologica - A.O.U. Luigi Vanvitelli
🇮🇹Napoli, Italy
U.O.C. Dermatologia . A.O.U. di Padova
🇮🇹Padova, Italy
Divisione di Ematologia - IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
U.O. Ematologia - Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
U.O.C. Ematologia - Policlinico Tor Vergata
🇮🇹Roma, Italy
UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano
🇮🇹Roma, Italy
U.O.C. Ematologia - A.O.U. Senese
🇮🇹Siena, Italy
S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Verona - AOU Integrata di Verona - U.O. Ematologia
🇮🇹Verona, Italy