PROSPER Study

  • Research type

    Research Study

  • Full title

    Prospective Research-based Observational Study of Poteligeo® Experience in the Real World in Adult Patients with Mycosis Fungoides and Sézary Syndrome

  • IRAS ID

    316849

  • Contact name

    Julia Scarisbrick

  • Contact email

    julia.scarisbrick@uhb.nhs.uk

  • Sponsor organisation

    Kyowa Kirin Services Ltd

  • Duration of Study in the UK

    2 years, months, days

  • Research summary

    Cutaneous T-cell lymphomas (CTCLs) are rare, initially indolent, non-Hodgkin lymphomas that present primarily in skin. The two best studied subtypes of CTCL are mycosis fungoides (MF) and Sézarysyndrome (SS).

    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.

    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 study will be conducted in up to 8 countries, including North America and countries in Europe, at approximately 20 sites known to treat and follow-up patients with MF/SS

    Patient data will be collected from available medical records. Patient data will be entered into the electronic data capture (EDC) system by the Investigator and/or qualified designee at the enrollment visit, at the Poteligeo® first dose visit, and approximately every 3 months thereafter.

    Patients will be followed for up to 50 weeks from study enrollment.

    Data will be collected from the patients and the patient's main caregiver through:
    - Symptom Diary and PRO questionnaires
    - Patient interviews
    - Photographs
    - Care Giver Oncology Quality of Life questionnaire (CarGOQoL) for the patient's main
    caregiver

    The study will not change the patient/physician relationship, nor influence the Investigator’s drug prescription or therapeutic management of the patient. The decision to treat patients with Poteligeo® will be independent from the decision to enroll patients in the study.

  • REC name

    London - Westminster Research Ethics Committee

  • REC reference

    22/PR/0874

  • Date of REC Opinion

    7 Sep 2022

  • REC opinion

    Further Information Favourable Opinion