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
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 Type
OBSERVATIONAL
Enrollment
100
Clinica di Ematologia - AOU Ospedali Riuniti delle Marche
Ancona, Italy
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
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To assess Progression Free Survival (PFS), Overall Survival (OS), Time to Next Treatment (TTNT)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Florence, Italy
S.C. Dermatologia - IRCCS Policlinico S. Martino
Genova, Italy
...and 11 more locations
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)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)