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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach

6 countries

19 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

July 4, 2022

Completed

9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed

4 months until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed

Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

July 4, 2022

Last Update Submit

September 3, 2024

Conditions

Mycosis Fungoides and Sézary Syndrome

Outcome Measures

Primary Outcomes (4)

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.

Study Arms (1)

Patients with MF/SS

Adult patients with diagnosed MF/SS receiving Poteligeo treatment.

Drug: Poteligeo

Interventions

PoteligeoDRUG

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.

Also known as: Mogamulizumab

Patients with MF/SS

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Kyowa Kirin Pharmaceutical Development Ltdlead

Study Sites (19)

The Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Colombia University Medical Center

New York, New York, 10032, United States

Location

Inova Dwight and Martha Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98105, United States

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona

Ancona, Italy

Location

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

Bologna, Italy

Location

Azienda Ospedaliero- Universitaria Careggi

Florence, Italy

Location

Ematologia Policlinico di Milano

Milan, Italy

Location

IFO-San Gallicano IRCCS

Rome, Italy

Location

Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli

Rome, Italy

Location

Leids Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Location

Hospital Del Mar

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Sheikh Shakhbout Medical City

Abu Dhabi, 11001, United Arab Emirates

Location

Clatterbridge Hospital - Wirral University Teaching Hospital Nhs Foundation Trust

Bebington, United Kingdom

Location

University Hospital Birmingham

Birmingham, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Nottingham University Hospitals NHS Trust - Nottingham City Hospital

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Mycosis FungoidesSezary Syndrome

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, CutaneousLymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Kyowa Kirin Medical Affairs Division
Kyowa Kirin Medical Affairs Division
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 13, 2022

Study Start

November 9, 2022

Primary Completion

August 7, 2025

Study Completion

August 7, 2025

Last Updated

September 4, 2024

Record last verified: 2024-09

Locations

US(5)NL(1)IT(6)AE(1)ES(2)GB(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Patients with MF/SS

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations