Clinical trial · Observational
Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma: a Multicenter Observational Study
NCT06113081CI-TRIAL-00113104FIL_MOGAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Cutaneous T-Cell Lymphoma/Mycosis Fungoides | Mycosis Fungoides | ALIAS | 0.90 |
| Cutaneous T-Cell Lymphoma/Sezary Syndrome | Sezary Syndrome | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients enrolled
- description
- Patients affected by relapsed/refractory Cutaneous T cell Lymphoma who have received Mogamulizumab in real life setting
Primary outcomes (1)
- measure
- To assess Overall response rate lasting at least 4 months (ORR4)
- timeFrame
- The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
- description
- Overall response lasting at least 4 months from response (CR+PR) to treatment with mogamulizumab
Secondary outcomes (6)
- measure
- To assess Frequencies of baseline characteristic compared with the expected from MAVORIC study
- timeFrame
- The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.