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NCT Number: NCT05455931

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

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.

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Key information

Conditions

Mycosis Fungoides and Sézary Syndrome Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Sezary Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Mogamulizumab

Primary outcomes

  1. To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo.

    Time frame: 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.

  2. To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo.

    Time frame: 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

  3. To describe the patient-reported change in health-related QoL following initiation of treatment with Poteligeo.

    Time frame: 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.

  4. To assess change in the HRQoL of the patient's main caregiver

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Industry

Registry information

Official study title

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

Acronym: PROSPER

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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