Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study
Overview
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Detailed description
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.
Primary outcome measures
- To evaluate the different systemic treatment approaches in real life settings in patients with CTCL. [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. [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. [Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
Secondary outcome measures (5)
- To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging). [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). [Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
- Overall Survival of enrolled patients. [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. [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). [Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.
- Age ≥18 years.
- Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.
- Availability of complete medical records in order to provide protocol required variables
- Signed written informed consent.
Exclusion criteria
- Patients not meeting the above-mentioned inclusion criteria.
- Refuse to sign a written informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 18 centers
- AOU Ospedali Riuniti delle Marche - Clinica di Ematologia — Ancona
- IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia — Bari
- U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale — Bari
- Policlinico S.Orsola-Malpighi - Istituto di Ematologia — Bologna
- ASST Spedali Civili di Brescia - S.C. Ematologia — Brescia
- A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO — Cagliari
- A.O.U. Policlinico S. Marco - U.O.C. di Ematologia — Catania
- Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi — Florence
- … and 10 more centers
Identifiers
NCT: NCT06588868 · FIL_CTCL