Clinical trial NCT06113081: Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
Official title: Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma: a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous T Cell Lymphoma
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Cutaneous T-Cell Lymphoma/Sezary Syndrome
Keywords: Cutaneous T Cell Lymphoma
Mycosis Fungoides
Sezary Syndrome
Mogamulizumab
MAVORIC
Retrospective
Relapsed
Refractory
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by relapsed/refractory Cutaneous T-cell Lymphoma who have received Mogamulizumab in real life settings

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess Overall response rate lasting at least 4 months (ORR4)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary outcomes:
measure: To assess Frequencies of baseline characteristic compared with the expected from MAVORIC study
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: To assess Overall response rate (ORR) at 1 month, ORR at 4 months and best ORR obtained from beginning of treatment with Mogamulizumab
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: To assess Logistic regression of ORR4 with peripheral blood involvement score
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: To assess Frequencies of adverse events collected with the clinical course
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: To assess Progression Free Survival (PFS), Overall Survival (OS), Time to Next Treatment (TTNT)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: 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
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Clinica di Ematologia - AOU Ospedali Riuniti delle Marche
city: Avellino
country: Italy
facility: S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati
city: Bari
country: Italy
facility: Clinica Dermatologia - A.O.U. Policlinico Consorziale
city: Bari
country: Italy
facility: U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
city: Bologna
country: Italy
facility: Istituto di Ematologia - Policlinico S.Orsola-Malpighi
city: Brescia
country: Italy
facility: S.C. Ematologia - ASST Spedali Civili
city: Cagliari
country: Italy
facility: S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco
city: Catania
country: Italy
facility: U.O.C. di Ematologia - A.O.U. Policlinico S. Marco
city: Firenze
country: Italy
facility: Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: S.C. Dermatologia - IRCCS Policlinico S. Martino
city: Genova
country: Italy
facility: S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino
city: Milano
country: Italy
facility: U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
city: Napoli
country: Italy
facility: Clinica Dermatologica - A.O.U. Luigi Vanvitelli
city: Padova
country: Italy
facility: U.O.C. Dermatologia . A.O.U. di Padova
city: Pavia
country: Italy
facility: Divisione di Ematologia - IRCCS Policlinico San Matteo
city: Piacenza
country: Italy
facility: U.O. Ematologia - Ospedale Guglielmo da Saliceto
city: Roma
country: Italy
facility: U.O.C. Ematologia - Policlinico Tor Vergata
city: Roma
country: Italy
facility: UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano
city: Siena
country: Italy
facility: U.O.C. Ematologia - A.O.U. Senese
city: Torino
country: Italy
facility: S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
city: Verona
country: Italy
facility: Verona - AOU Integrata di Verona - U.O. Ematologia
Study officials:
affiliation: SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
name: Pietro Quaglino, MD
role: PRINCIPAL_INVESTIGATOR
References: