Clinical trial NCT05455931: Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)
Official title: Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mycosis Fungoides and Sézary Syndrome
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
measure: 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.
measure: 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.
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University School of Medicine
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Colombia University Medical Center
state: New York
city: Fairfax
country: United States
facility: Inova Dwight and Martha Schar Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona
city: Bologna
country: Italy
facility: IRCCS A.O.U. Policlinico S. Orsola - Malpighi
city: Florence
country: Italy
facility: Azienda Ospedaliero- Universitaria Careggi
city: Milan
country: Italy
facility: Ematologia Policlinico di Milano
city: Rome
country: Italy
facility: IFO-San Gallicano IRCCS
city: Rome
country: Italy
facility: Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City
city: Bebington
country: United Kingdom
facility: Clatterbridge Hospital - Wirral University Teaching Hospital Nhs Foundation Trust
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Study officials:
affiliation: Kyowa Kirin Medical Affairs Division
name: Kyowa Kirin Medical Affairs Division
role: STUDY_DIRECTOR
References: