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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mycosis Fungoides and Sézary Syndrome
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona
  • Bologna, Italy
    • IRCCS A.O.U. Policlinico S. Orsola - Malpighi
  • Florence, Italy
    • Azienda Ospedaliero- Universitaria Careggi
  • Milan, Italy
    • Ematologia Policlinico di Milano
  • Rome, Italy
    • IFO-San Gallicano IRCCS
  • Rome, Italy
    • Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli
• Netherlands
  • Leiden, Netherlands
    • Leids Universitair Medisch Centrum (LUMC)
• Spain
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 11001
    • Sheikh Shakhbout Medical City
• United Kingdom
  • Bebington, United Kingdom
    • Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust
  • Birmingham, United Kingdom
    • University Hospital Birmingham
  • Manchester, United Kingdom
    • The Christie NHS Foundation Trust
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust - Nottingham City Hospital
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • The Johns Hopkins University School of Medicine
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10032
      • Colombia University Medical Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Dwight and Martha Schar Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98105
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with MF/SS; Adult patients with diagnosed MF/SS receiving Poteligeo treatment.

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.; Other Names: Mogamulizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd
• Investigators: Study Director: Kyowa Kirin Medical Affairs Division, Kyowa Kirin Medical Affairs Division

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): August 7, 2025
• Study Completion (Estimated): August 7, 2025

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Disease; Bacterial Infections and Mycoses; Lymphoma; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Syndrome; Mycoses; Mycosis Fungoides; Sezary Syndrome; Antineoplastic Agents; Mogamulizumab
• Other Study ID Numbers: 2022-05-WW-POT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No