Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)
- Registration Number
- NCT05455931
- Lead Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with MF/SS Poteligeo Adult patients with diagnosed MF/SS receiving Poteligeo treatment.
- Primary Outcome Measures
Name Time Method To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo. Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation. Patients will complete PRO questionnaire BFI to assess changes in fatigue
To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo. Weekly for first 16 weeks, then every 4 weeks until Week 48, at treatment discontinuation and 8 and 16 weeks after treatment discontinuation. Patients will complete a symptom diary at regular intervals throughout the study to record symptoms including skin pain, skin itch, skin flaking, skin redness, difficulty regulating body temperature and sleep problems.
To describe the patient-reported change in health-related QoL following initiation of treatment with Poteligeo. Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation. Patients will complete PRO questionnaire CTCL-QoL at regular time points throughout the study to assess any changes in quality of life.
To assess change in the HRQoL of the patient's main caregiver First dose visit, at week 12 after the first Poteligeo® administration, and within 4 weeks of treatment discontinuation. The patient's main caregiver will be invited to complete the CareGiver Oncology Quality of Life questionnaire (CarGOQoL)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Colombia University Medical Center
🇺🇸New York, New York, 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
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Sheikh Shakhbout Medical City
🇦🇪Abu Dhabi, United Arab Emirates
Clatterbridge Hospital - Wirral University Teaching Hospital Nhs Foundation Trust
🇬🇧Bebington, United Kingdom
University Hospital Birmingham
🇬🇧Birmingham, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Inova Dwight and Martha Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States