Evaluating the use of mogamulizumab for treating cutaneous T-cell lymphoma
Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma: a Multicenter Observational Study
This study is testing how well mogamulizumab works and how safe it is for people with cutaneous T-cell lymphoma who have already had other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | mogamulizumab |
| Locations | 21 sites (Ancona and 20 other locations) |
| Trial ID | NCT06113081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the clinical activity and safety profile of mogamulizumab in patients with cutaneous T-cell lymphoma (CTCL) who have previously undergone systemic therapy. The study focuses on patients who have received mogamulizumab at the standard approved dose after its reimbursement in Italy. By analyzing patient outcomes in a clinical practice setting, the study seeks to confirm the efficacy and safety of mogamulizumab as observed in earlier clinical trials. This research is essential for understanding how the drug performs outside of controlled trial environments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of cutaneous T-cell lymphoma who have failed at least one previous systemic therapy.
Not a fit: Patients who do not meet the inclusion criteria, such as those without a confirmed diagnosis of CTCL or who have not received mogamulizumab, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of mogamulizumab for patients with cutaneous T-cell lymphoma in real-world settings.
How similar studies have performed: While this study builds on the findings of the MAVORIC trial, it aims to provide novel real-world evidence that has not yet been extensively documented.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: • Patients not meeting the above-mentioned inclusion criteria
Where this trial is running
Ancona and 20 other locations
- Clinica di Ematologia - AOU Ospedali Riuniti delle Marche — Ancona, Italy (Recruiting)
- S.C. Ematologia e Trapianto emopoietico - A.O. S.Giuseppe Moscati — Avellino, Italy (Recruiting)
- Clinica Dermatologia - A.O.U. Policlinico Consorziale — Bari, Italy (Not_yet_recruiting)
- U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II — Bari, Italy (Not_yet_recruiting)
- Istituto di Ematologia - Policlinico S.Orsola-Malpighi — Bologna, Italy (Recruiting)
- S.C. Ematologia - ASST Spedali Civili — Brescia, Italy (Recruiting)
- S.C. Ematologia e CTMO - A.O. Brotzu Ospedale Businco — Cagliari, Italy (Not_yet_recruiting)
- U.O.C. di Ematologia - A.O.U. Policlinico S. Marco — Catania, Italy (Not_yet_recruiting)
- Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi — Firenze, Italy (Recruiting)
- S.C. Dermatologia - IRCCS Policlinico S. Martino — Genova, Italy (Recruiting)
- S.C. Ematologia e Terapie Cellulari - IRCCS Policlinico S. Martino — Genova, Italy (Not_yet_recruiting)
- U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda — Milano, Italy (Recruiting)
- Clinica Dermatologica - A.O.U. Luigi Vanvitelli — Napoli, Italy (Not_yet_recruiting)
- U.O.C. Dermatologia . A.O.U. di Padova — Padova, Italy (Not_yet_recruiting)
- Divisione di Ematologia - IRCCS Policlinico San Matteo — Pavia, Italy (Not_yet_recruiting)
- U.O. Ematologia - Ospedale Guglielmo da Saliceto — Piacenza, Italy (Recruiting)
- U.O.C. Ematologia - Policlinico Tor Vergata — Roma, Italy (Not_yet_recruiting)
- UOSD Porfirie e Malattie Rare - IRCCS I.F.O. San Gallicano — Roma, Italy (Recruiting)
- U.O.C. Ematologia - A.O.U. Senese — Siena, Italy (Not_yet_recruiting)
- S.C. Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino — Torino, Italy (Recruiting)
- Verona - AOU Integrata di Verona - U.O. Ematologia — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Pietro Quaglino, MD — SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
- Study coordinator: Uffici Studi FIL
- Email: startup@filinf.it
- Phone: +390131033153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.