Mycosis Fungoides and Sézary Syndrome
Conditions
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.
Interventions
DRUGPoteligeo
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.
Sponsors
Kyowa Kirin Pharmaceutical Development Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient aged ≥18 years 2. Confirmed diagnosis of MF/SS 3. Disease staging at enrollment has been completed 4. About to commence primary treatment with Poteligeo® as per reimbursed indication 5. Patient is willing and able to complete the symptom diary and PROs. 6. 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
1. Patient unable to participate in all aspects of the study and/or does not agree to the collection of data from medical records 2. Patient currently participating in an interventional clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) |
Countries
Italy, Netherlands, Spain, United Arab Emirates, United Kingdom, United States
Contacts
STUDY_DIRECTORKyowa Kirin Medical Affairs Division
Kyowa Kirin Medical Affairs Division
Outcome results
None listed