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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients enrolled | Patients affected by relapsed/refractory Cutaneous T cell Lymphoma who have received Mogamulizumab in real life setting |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) |
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Inclusion Criteria:
Exclusion Criteria:
• Patients not meeting the above-mentioned inclusion criteria
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Patients affected by relapsed/refractory Cutaneous T-cell Lymphoma who have received Mogamulizumab in real life settings
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| 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 |
|---|---|---|---|---|---|---|
| Clinica di Ematologia - AOU Ospedali Riuniti delle Marche | Ancona | Italy | ||||
| S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati |
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| 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 | 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 | 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 | 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) | 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) | 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 | The endpoint will be evaluated from the beginning to the end of the study (up to 18 months) |
| 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 |
| S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino | Genova | Italy |
| U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda | Milan | Italy |
| Clinica Dermatologica - A.O.U. Luigi Vanvitelli | Naples | Italy |
| U.O.C. Dermatologia . A.O.U. di Padova | Padova | Italy |
| Divisione di Ematologia - IRCCS Policlinico San Matteo | Pavia | Italy |
| U.O. Ematologia - Ospedale Guglielmo da Saliceto | Piacenza | Italy |
| U.O.C. Ematologia - Policlinico Tor Vergata | Roma | Italy |
| UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano | Roma | Italy |
| U.O.C. Ematologia - A.O.U. Senese | Siena | Italy |
| S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino | Torino | Italy |
| Verona - AOU Integrata di Verona - U.O. Ematologia | Verona | 37134 | Italy |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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