NCT05455931

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

Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The PROSPER study aims to collect information about the experiences of patients with MF/SS receiving Poteligeo and of their caregivers in real-world clinical practice. The objective of this study is to generate patient-level data to provide insights into real world clinical practice and an understanding of treatment decisions, as well as to collect patient reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience and burden, to demonstrate the full impact of treatment and the relevant patient experience in real-world clinical practice. The study will be conducted 6 countries, including North America, United Arab Emirates and countries in Europe, at 19 sites known to treat and follow-up patients with MF/SS. Patients will be followed for up to 50 weeks from study enrollment.

Conditions

• Mycosis Fungoides and Sézary Syndrome

Interventions

Type	Name	Description
DRUG	Poteligeo	Poteligeo treatment will be used as prescribed by the Investigator in accordance with the terms of the reimbursed indication within the relevant country. The assignment of the patient to a particular therapeutic strategy falls within current practice and the prescription of Poteligeo is clearly separated from the decision to include the patient in the study.

Timeline

• Start date: 2022-11-09
• Primary completion: 2025-08-07
• Completion: 2025-08-07
• First posted: 2022-07-13
• Last updated: 2024-09-04

Locations

19 sites across 6 countries: United States, Italy, Netherlands, Spain, United Arab Emirates, United Kingdom