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

Cutaneous T Cell Lymphoma Clinical Trial

— FIL_MOGA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113081
• Other study ID #: FIL_MOGA
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Fondazione Italiana Linfomi - ETS
• Contact: Uffici Studi FIL
• Phone: +390131033153
• Email: startup[@]filinf.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous T Cell Lymphoma
• Cutaneous T-Cell Lymphoma/Mycosis Fungoides
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome

Locations

Country	Name	City	State
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	U.O.C. di Ematologia - A.O.U. Policlinico S. Marco	Catania
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess Frequencies of baseline characteristic compared with the expected from MAVORIC study	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	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary	To assess Overall response rate (ORR) at 1 month, ORR at 4 months and best ORR obtained from beginning of treatment with Mogamulizumab	Evaluate the early and late activity of mogamulizumab	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary	To assess Logistic regression of ORR4 with peripheral blood involvement score	To identify whether the presence of a B1 B2 score is associated with a higher response rate in the skin, compared to B0	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary	To assess Frequencies of adverse events collected with the clinical course	To investigate whether the presence of a cutaneous side effect is associated with a different clinical course and high response rate	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary	To assess Progression Free Survival (PFS), Overall Survival (OS), Time to Next Treatment (TTNT)	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)	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary	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	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	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)