Active not recruitingOBSERVATIONAL

Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)

The PROSPER study is an international project designed to understand the real-world experiences of adults with skin conditions called Mycosis Fungoides (MF) and Sézary Syndrome (SS) who are being treated with Poteligeo. It’s not a trial testing a new medicine, but rather an observational study. This means researchers are simply watching and learning about how things are going for patients and their caregivers in their everyday lives, once treatment has started. They will gather information on treatment decisions, patient well-being, and how the disease and its treatment affect daily life. The study aims to provide a full picture of the treatment's impact from the patient's point of view, over a period of up to 50 weeks.

At a glance

Status

Active not recruiting

Sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Enrolment target

Start

09 Nov 2022

Estimated completion

07 Aug 2025

Mycosis Fungoides and Sézary Syndrome

What is this study about?

The PROSPER study is an international research project that wants to understand more about two types of skin lymphoma, called Mycosis Fungoides (MF) and Sézary Syndrome (SS). If you have one of these conditions and are starting treatment with a medicine called Poteligeo, this study might be for you. It's not a study where new treatments are tested; instead, it observes what happens in real life for patients already receiving Poteligeo.

The main goal is to collect detailed information directly from patients and their caregivers. This helps doctors and researchers understand what it’s like to live with MF/SS and how Poteligeo affects your daily life, your well-being, and the decisions made about your care. By gathering these real-world experiences, including how you feel and what challenges you face, the study hopes to show the full impact of the treatment.

This study will take place in 19 medical centres across six different countries, including North America, the United Arab Emirates, and several European countries. This wide reach helps to get a broad understanding of patient experiences. Your participation would help build a better picture of how Poteligeo works in practice for different people, which can then help future patients and improve care.

Key takeaways

It's a study about real-world experiences with Poteligeo for MF/SS.
It’s for adults about to start Poteligeo treatment.
Participation involves sharing your experiences through diaries and questionnaires.
No extra hospital visits or medical procedures are required.
Your input helps others and improves understanding of the treatment.
You can stop participating at any time.

Who may be eligible?

To join the PROSPER study, you need to be at least 18 years old and have a confirmed diagnosis of Mycosis Fungoides (MF) or Sézary Syndrome (SS). You should be about to start taking the medicine Poteligeo for the first time, as prescribed by your doctor.

It’s important that you are willing and able to fill out symptom diaries and questionnaires about your health and how you're feeling. You also need to be able to give written permission (informed consent) to take part in the study, which will be explained clearly to you.

You cannot join if you are already taking part in another clinical trial where you are given a specific treatment to test. Also, you must be able to follow all the study's instructions and agree for the researchers to look at your medical records.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Mycosis Fungoides (MF) or Sézary Syndrome (SS)?
Are you about to start Poteligeo for the first time?
Are you willing to fill out symptom diaries and questionnaires?
Are you NOT currently in another clinical trial where you receive a specific treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the PROSPER study, you will be followed for up to 50 weeks after you start your Poteligeo treatment. This is an observational study, which means you will receive your Poteligeo treatment as you normally would, based on your doctor's decisions.

The main part of your participation will involve completing symptom diaries and questionnaires (called Patient Reported Outcomes, or PROs). These help researchers understand how you feel and how the treatment is affecting you over time. You will also allow the study team to collect information from your regular medical records. There are no additional visits or tests specifically for the study beyond your usual appointments with your doctor.

Potential risks and benefits

There are no direct medical benefits from taking part in this study, as you will receive your treatment exactly as your doctor would prescribe it anyway. However, your participation will help doctors and researchers gain a better understanding of how Poteligeo works in real-world settings and how it affects patients' daily lives. This knowledge can help improve care for others in the future. As this is an observational study, there are no specific medical risks directly from participating, beyond the known risks and side effects of Poteligeo itself, which your doctor will discuss with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (19)

The Johns Hopkins University School of Medicine
Baltimore, United States
Washington University School of Medicine
St Louis, United States
Colombia University Medical Center
New York, United States
Inova Dwight and Martha Schar Cancer Institute
Fairfax, United States
Fred Hutchinson Cancer Center
Seattle, United States
Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona
Ancona, Italy
IRCCS A.O.U. Policlinico S. Orsola - Malpighi
Bologna, Italy
Azienda Ospedaliero- Universitaria Careggi
Florence, Italy
Ematologia Policlinico di Milano
Milan, Italy
IFO-San Gallicano IRCCS
Rome, Italy
Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli
Rome, Italy
Leids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands

+7 more sites — see the official record for the full list.

Common questions

What is Poteligeo?

Poteligeo is a medicine used to treat certain types of skin lymphoma, including Mycosis Fungoides and Sézary Syndrome, for adult patients.

Is this a clinical trial where I might get a placebo?

No, this is an observational study. You will receive Poteligeo as prescribed by your doctor and not a placebo. The study simply watches how the treatment works in real-life situations.

How long will I be involved in the study?

If you join, you will be followed for up to 50 weeks from when you start the study.

Do I need to visit the hospital more often for this study?

No, you will not have any extra hospital visits for the study itself. All data will be collected during your regular medical appointments and through questionnaires you complete.

Will my personal details be kept private?

Yes, all information collected will be treated with strict confidentiality and used in a way that protects your privacy.