Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma (NCT06113081) | Clinical Trial Compass
CompletedNot Applicable
Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
Italy100 participantsStarted 2024-06-06
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study looked at how mogamulizumab performs in real-world patients with cutaneous T-cell lymphoma rather than in a controlled trial setting, can you tell me whether the response rates seen here are relevant to someone with my specific type — whether that's mycosis fungoides or Sézary syndrome?
2The main thing this study measured was whether patients had a response lasting at least 4 months — what would a response of that length actually mean for my day-to-day quality of life, and how does that compare to what I might expect from other available treatments?
3Since this study is already completed, does the data it generated change your thinking about whether mogamulizumab would be a good fit for me at this point in my treatment, or would you recommend trying other options first?
4Mogamulizumab is already FDA-approved for cutaneous T-cell lymphoma — given that this was a real-world study rather than an early-phase safety trial, what do we know so far about the side effects I should watch out for if I were to consider this drug?
5Are there patient characteristics from this real-world study — such as how advanced the disease was or prior treatments people had received — that might help us figure out whether my situation is similar to the patients who responded well?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)