Status:

COMPLETED

Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma

Lead Sponsor:

Fondazione Italiana Linfomi - ETS

Conditions:

Cutaneous T Cell Lymphoma

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Eligibility:

All Genders

18+ years

Brief Summary

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

Detailed Description

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 o...

Eligibility Criteria

Inclusion

  • Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria (Trautinger et al, Eur J Cancer, 2017)
  • Age ≥18 years
  • Have failed at least one previous line of systemic therapy
  • Have received mogamulizumab in real life setting after the approval and reimbursement of the drug from the National Health System in December 2020
  • Have received first dose of mogamulizumab between 01/01/2021 and 31/01/2023
  • Have received mogamulizumab at the standard approved dose (1.0 mg/kg intravenously on days 1, 8, 15 and 22 of the first cycle and on days 1 and 15 of subsequent cycles)
  • Availability of complete medical records.

Exclusion

  • • Patients not meeting the above-mentioned inclusion criteria

Key Trial Info

Start Date :

June 6 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 11 2025

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06113081

Start Date

June 6 2024

End Date

November 11 2025

Last Update

December 24 2025

Active Locations (21)

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Page 1 of 6 (21 locations)

1

Clinica di Ematologia - AOU Ospedali Riuniti delle Marche

Ancona, Italy

2

S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati

Avellino, Italy

3

Clinica Dermatologia - A.O.U. Policlinico Consorziale

Bari, Italy

4

U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II

Bari, Italy

Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma | DecenTrialz