Trial Title:
Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
NCT ID:
NCT06113081
Condition:
Cutaneous T Cell Lymphoma
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Cutaneous T-Cell Lymphoma/Sezary Syndrome
Conditions: Official terms:
Mycoses
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Conditions: Keywords:
Cutaneous T Cell Lymphoma
Mycosis Fungoides
Sezary Syndrome
Mogamulizumab
MAVORIC
Retrospective
Relapsed
Refractory
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
Patients affected by relapsed/refractory Cutaneous T-cell Lymphoma who have received
Mogamulizumab in real life settings
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinica di Ematologia - AOU Ospedali Riuniti delle Marche
Address:
City:
Ancona
Country:
Italy
Contact:
Last name:
Serena Rupoli, MD
Email:
serena.rupoli@ospedaliriuniti.marche.it
Investigator:
Last name:
Serena Rupoli, MD
Email:
Principal Investigator
Facility:
Name:
S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati
Address:
City:
Avellino
Country:
Italy
Contact:
Last name:
Sonya De Lorenzo, MD
Email:
sonya.delorenzo@tin.it
Investigator:
Last name:
Sonya De Lorenzo, MD
Email:
Principal Investigator
Facility:
Name:
Clinica Dermatologia - A.O.U. Policlinico Consorziale
Address:
City:
Bari
Country:
Italy
Contact:
Last name:
Raffaele Filotico, MD
Email:
raffaele.filotico@uniba.it
Investigator:
Last name:
Raffaele Filotico, MD
Email:
Principal Investigator
Facility:
Name:
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Address:
City:
Bari
Country:
Italy
Contact:
Last name:
Giacomo Loseto, MD
Email:
loseto.giacomo@gmail.com
Investigator:
Last name:
Giacomo Loseto, MD
Email:
Principal Investigator
Facility:
Name:
Istituto di Ematologia - Policlinico S.Orsola-Malpighi
Address:
City:
Bologna
Country:
Italy
Contact:
Last name:
Pier Luigi Zinzani, MD
Email:
pierluigi.zinzani@unibo.it
Investigator:
Last name:
Pier Luigi Zinzani, MD
Email:
Principal Investigator
Facility:
Name:
S.C. Ematologia - ASST Spedali Civili
Address:
City:
Brescia
Country:
Italy
Contact:
Last name:
Alessandra Tucci, MD
Email:
alessandra.tucci@asst-spedalicivili.it
Investigator:
Last name:
Alessandra Tucci, MD
Email:
Principal Investigator
Facility:
Name:
S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco
Address:
City:
Cagliari
Country:
Italy
Contact:
Last name:
Maria Pina Simula, MD
Email:
mariap.simula@aob.it
Investigator:
Last name:
Maria Pina Simula, MD
Email:
Principal Investigator
Facility:
Name:
U.O.C. di Ematologia - A.O.U. Policlinico S. Marco
Address:
City:
Catania
Country:
Italy
Contact:
Last name:
Amalia Figuera, MD
Email:
amaliafiguera@gmail.com
Investigator:
Last name:
Amalia Figuera, MD
Email:
Principal Investigator
Facility:
Name:
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Country:
Italy
Contact:
Last name:
Luca Nassi, MD
Email:
nassil@aou-careggi.toscana.it
Investigator:
Last name:
Luca Nassi, MD
Email:
Principal Investigator
Facility:
Name:
S.C. Dermatologia - IRCCS Policlinico S. Martino
Address:
City:
Genova
Country:
Italy
Contact:
Last name:
Cesare Massone, MD
Email:
cesare.massone@gmail.com
Investigator:
Last name:
Cesare Massone, MD
Email:
Principal Investigator
Facility:
Name:
S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino
Address:
City:
Genova
Country:
Italy
Contact:
Last name:
Adalberto Ibatici, MD
Email:
adalberto.ibatici@hsanmartino.it
Investigator:
Last name:
Adalberto Ibatici, MD
Email:
Principal Investigator
Facility:
Name:
U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
Address:
City:
Milano
Country:
Italy
Contact:
Last name:
Silvia Alberti Violetti, MD
Email:
silvia.albertivioletti@gmail.com
Investigator:
Last name:
Silvia Alberti Violetti, MD
Email:
Principal Investigator
Facility:
Name:
Clinica Dermatologica - A.O.U. Luigi Vanvitelli
Address:
City:
Napoli
Country:
Italy
Contact:
Last name:
Paola Vitiello, MD
Email:
paoladermosun@gmail.com
Investigator:
Last name:
Paola Vitiello, MD
Email:
Principal Investigator
Facility:
Name:
U.O.C. Dermatologia . A.O.U. di Padova
Address:
City:
Padova
Country:
Italy
Contact:
Last name:
Mauro Alaibac, MD
Email:
mauro.alaibac@unipd.it
Investigator:
Last name:
Mauro Ailaibac, MD
Email:
Principal Investigator
Facility:
Name:
Divisione di Ematologia - IRCCS Policlinico San Matteo
Address:
City:
Pavia
Country:
Italy
Contact:
Last name:
Luca Arcaini, MD
Email:
luca.arcaini@unipv.it
Investigator:
Last name:
Luca Arcaini, MD
Email:
Principal Investigator
Facility:
Name:
U.O. Ematologia - Ospedale Guglielmo da Saliceto
Address:
City:
Piacenza
Country:
Italy
Contact:
Last name:
Patrizia Bernuzzi, MD
Email:
p.bernuzzi@ausl.pc.it
Investigator:
Last name:
Patrizia Bernuzzi, MD
Email:
Principal Investigator
Facility:
Name:
U.O.C. Ematologia - Policlinico Tor Vergata
Address:
City:
Roma
Country:
Italy
Contact:
Last name:
Massimiliano Postorino, MD
Email:
massimiliano.postorino@ptvonline.it
Investigator:
Last name:
Massimiliano Postorino, MD
Email:
Principal Investigator
Facility:
Name:
UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano
Address:
City:
Roma
Country:
Italy
Contact:
Last name:
Marco Ardigò, MD
Email:
marco.ardigo@ifo.it
Investigator:
Last name:
Marco Ardigò, MD
Email:
Principal Investigator
Facility:
Name:
U.O.C. Ematologia - A.O.U. Senese
Address:
City:
Siena
Country:
Italy
Contact:
Last name:
Alberto Fabbri, MD
Email:
fabbri7@unisi.it
Investigator:
Last name:
Alberto Fabbri, MD
Email:
Principal Investigator
Facility:
Name:
S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
Address:
City:
Torino
Country:
Italy
Contact:
Last name:
Pietro Quaglino, MD
Email:
pietro.quaglino@unito.it
Investigator:
Last name:
Pietro Quaglino, MD
Email:
Principal Investigator
Start date:
January 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06113081
