The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies). Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials. This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Study Type
OBSERVATIONAL
Enrollment
400
AOU Ospedali Riuniti delle Marche - Clinica di Ematologia
Ancona, Italy
RECRUITINGTo evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Type of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Frequency of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).
Frequency of baseline characteristics.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).
Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari, Italy
RECRUITINGU.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale
Bari, Italy
NOT_YET_RECRUITINGPoliclinico S.Orsola-Malpighi - Istituto di Ematologia
Bologna, Italy
RECRUITINGASST Spedali Civili di Brescia - S.C. Ematologia
Brescia, Italy
NOT_YET_RECRUITINGA.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO
Cagliari, Italy
NOT_YET_RECRUITINGA.O.U. Policlinico S. Marco - U.O.C. di Ematologia
Catania, Italy
NOT_YET_RECRUITINGUnità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Florence, Italy
RECRUITINGS.C. Dermatologia - E.O. Galliera
Genova, Italy
RECRUITINGOncoematologia - ASST Fatebenefratelli - Sacco
Milan, Italy
NOT_YET_RECRUITING...and 8 more locations
Overall Survival of enrolled patients.
Overall Survival
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the safety of each different systemic treatments.
Frequency of adverse events collected with the clinical course.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Impact of new drugs (brentuximab vedotin and mogamulizumab).
Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)