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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients enrolled | 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 a real life setting. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging). | Frequency of baseline characteristics. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | +390131033153 | startup@filinf.it | |
| Uffici Studi FIL | Contact | +390599769913 | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Pietro Quaglino, MD | SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Ospedali Riuniti delle Marche - Clinica di Ematologia | Recruiting | Ancona | Italy |
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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. |
| The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) |
| Overall Survival of enrolled patients. | Overall Survival | 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. | 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. | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) |
| IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia | Recruiting | Bari | Italy |
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| U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale | Not yet recruiting | Bari | Italy |
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| Policlinico S.Orsola-Malpighi - Istituto di Ematologia | Recruiting | Bologna | Italy |
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| ASST Spedali Civili di Brescia - S.C. Ematologia | Not yet recruiting | Brescia | Italy |
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| A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO | Not yet recruiting | Cagliari | Italy |
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| A.O.U. Policlinico S. Marco - U.O.C. di Ematologia | Not yet recruiting | Catania | Italy |
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| Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi | Recruiting | Florence | Italy |
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| S.C. Dermatologia - E.O. Galliera | Recruiting | Genova | Italy |
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| Oncoematologia - ASST Fatebenefratelli - Sacco | Not yet recruiting | Milan | Italy |
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| U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda | Recruiting | Milan | Italy |
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| U.O.C. Clinica Dermatologica - A.O.U. di Padova | Not yet recruiting | Padova | Italy |
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| U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo | Not yet recruiting | Pavia | Italy |
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| IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare | Recruiting | Roma | Italy |
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| Skin Cancer Center - IRCCS Istituto Dermopatico dell'Immacolata | Not yet recruiting | Roma | Italy |
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| U.O.C. Dermatologia - A.O.U. Senese | Not yet recruiting | Siena | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino - S.C. Dermatologia U | Recruiting | Torino | Italy |
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| A.O.U.I. di Verona - U.O.C. Ematologia | Recruiting | Verona | Italy |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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