Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER) (NCT05455931) | Clinical Trial Compass
CompletedNot Applicable
Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)
United States, Italy, Netherlands73 participantsStarted 2022-11-09
Plain-language summary
This is a prospective, observational, non-interventional, international, multi-center, mixed methods study that will involve the integration of quantitative and qualitative data in patients with MF/SS treated with Poteligeo.
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
. Patient aged ≥18 years
. Confirmed diagnosis of MF/SS
. Disease staging at enrollment has been completed
. About to commence primary treatment with Poteligeo® as per reimbursed indication
. Patient is willing and able to complete the symptom diary and PROs.
. Patient is willing and able to provide written informed consent to participate in the study in a manner approved by Institutional Review Board(IRB)/ Independent Ethics Committee (IEC) and local regulations
Exclusion criteria
. Patient unable to participate in all aspects of the study and/or does not agree to the collection of data from medical records
. Patient currently participating in an interventional clinical trial
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo.
Timeframe: Weekly for first 16 weeks, then every 4 weeks until Week 48, at treatment discontinuation and 8 and 16 weeks after treatment discontinuation.
2
To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo.
Timeframe: Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation.
3
To describe the patient-reported change in health-related QoL following initiation of treatment with Poteligeo.
Timeframe: Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation.
4
To assess change in the HRQoL of the patient's main caregiver
Timeframe: First dose visit, at week 12 after the first Poteligeo® administration, and within 4 weeks of treatment discontinuation.