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Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

ConditionsCutaneous T Cell LymphomaCutaneous T-Cell Lymphoma/Mycosis FungoidesCutaneous T-Cell Lymphoma/Sezary Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS

About this trial

The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients not meeting the above-mentioned inclusion criteria.

Refuse to sign a written informed consent.

Trial population

Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in real life settings

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Patients enrolled

Trial outcomes

Primary outcomes

1

To 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)
2

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)
3

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Italiana Linfomi - ETS

Lead sponsor

Takeda

Collaborator

Source ClinicalTrials.gov
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