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

Last updated: September 3, 2024
Sponsor: Kyowa Kirin Pharmaceutical Development Ltd
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sezary Syndrome

Lymphoproliferative Disorders

Mycosis Fungoides

Treatment

Poteligeo

Clinical Study ID

NCT05455931
2022-05-WW-POT
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inthe study in a manner approved by Institutional Review Board(IRB)/ IndependentEthics Committee (IEC) and local regulations

Exclusion

Exclusion Criteria:

  1. Patient unable to participate in all aspects of the study and/or does not agree tothe collection of data from medical records

  2. Patient currently participating in an interventional clinical trial

Study Design

Total Participants: 73
Treatment Group(s): 1
Primary Treatment: Poteligeo
Phase:
Study Start date:
November 09, 2022
Estimated Completion Date:
August 07, 2025

Study 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.

Connect with a study center

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona

    Ancona,
    Italy

    Site Not Available

  • IRCCS A.O.U. Policlinico S. Orsola - Malpighi

    Bologna,
    Italy

    Site Not Available

  • Azienda Ospedaliero- Universitaria Careggi

    Florence,
    Italy

    Site Not Available

  • Centro Trapianti di Midollo Osseo-Centro Trapianti di Midollo Osseog

    Milan,
    Italy

    Site Not Available

  • Ematologia Policlinico di Milano

    Milan,
    Italy

    Site Not Available

  • IFO-San Gallicano IRCCS

    Rome,
    Italy

    Site Not Available

  • Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli

    Rome,
    Italy

    Site Not Available

  • AOU Citta della Salute e della Scienza di Torino

    Turin,
    Italy

    Site Not Available

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden,
    Netherlands

    Site Not Available

  • Hospital Del Mar

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

    Madrid,
    Spain

    Site Not Available

  • Sheikh Shakhbout Medical City

    Abu Dhabi, 11001
    United Arab Emirates

    Site Not Available

  • Clatterbridge Hospital - Wirral University Teaching Hospital Nhs Foundation Trust

    Bebington,
    United Kingdom

    Site Not Available

  • University Hospital Birmingham

    Birmingham,
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester,
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham,
    United Kingdom

    Site Not Available

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Colombia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York 10065
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Inova Dwight and Martha Schar Cancer Institute

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98105
    United States

    Site Not Available

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