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

Sponsor

Fondazione Italiana Linfomi - ETS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06113081

Collaborator

(none)

150

Enrollment

Locations

Anticipated Duration (Months)

7.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T Cell Lymphoma Cutaneous T-Cell Lymphoma/Mycosis Fungoides Cutaneous T-Cell Lymphoma/Sezary Syndrome

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Clinica di Ematologia - AOU Ospedali Riuniti delle Marche	Ancona	Italy
2	S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati	Avellino	Italy
3	Clinica Dermatologia - A.O.U. Policlinico Consorziale	Bari	Italy
4	U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II	Bari	Italy
5	Istituto di Ematologia - Policlinico S.Orsola-Malpighi	Bologna	Italy
6	S.C. Ematologia - ASST Spedali Civili	Brescia	Italy
7	S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco	Cagliari	Italy
8	U.O.C. di Ematologia - A.O.U. Policlinico S. Marco	Catania	Italy
9	Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi	Firenze	Italy
10	S.C. Dermatologia - IRCCS Policlinico S. Martino	Genova	Italy
11	S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino	Genova	Italy
12	U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda	Milano	Italy
13	Clinica Dermatologica - A.O.U. Luigi Vanvitelli	Napoli	Italy
14	U.O.C. Dermatologia . A.O.U. di Padova	Padova	Italy
15	Divisione di Ematologia - IRCCS Policlinico San Matteo	Pavia	Italy
16	U.O. Ematologia - Ospedale Guglielmo da Saliceto	Piacenza	Italy
17	U.O.C. Ematologia - Policlinico Tor Vergata	Roma	Italy
18	UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano	Roma	Italy
19	U.O.C. Ematologia - A.O.U. Senese	Siena	Italy
20	S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino	Torino	Italy