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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MF/SS | Adult patients with diagnosed MF/SS receiving Poteligeo treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poteligeo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo. | 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. | Weekly for first 16 weeks, then every 4 weeks until Week 48, at treatment discontinuation and 8 and 16 weeks after treatment discontinuation. |
| To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo. | Patients will complete PRO questionnaire BFI to assess changes in fatigue | Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation. |
| To describe the patient-reported change in health-related QoL following initiation of treatment with Poteligeo. | Patients will complete PRO questionnaire CTCL-QoL at regular time points throughout the study to assess any changes in quality of life. | Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation. |
| To assess change in the HRQoL of the patient's main caregiver | The patient's main caregiver will be invited to complete the CareGiver Oncology Quality of Life questionnaire (CarGOQoL) | First dose visit, at week 12 after the first Poteligeo® administration, and within 4 weeks of treatment discontinuation. |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 80 patients with a confirmed diagnosis of MF/SS and about to commence primary treatment with Poteligeo as per reimbursed indication will be recruited from approximately 19 sites across North America, United Arab Emirates and Europe.
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| Name | Affiliation | Role |
|---|---|---|
| Kyowa Kirin Medical Affairs Division | Kyowa Kirin Medical Affairs Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States | ||
| Washington University School of Medicine |
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|
|
| St Louis |
| Missouri |
| 63108 |
| United States |
| Colombia University Medical Center | New York | New York | 10032 | United States |
| Inova Dwight and Martha Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98105 | 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 | Abu Dhabi Emirate | 11001 | 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 |
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C549035 | mogamulizumab |
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