Mycosis Fungoides and Sézary SyndromePROSPERNCT05455931
Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)
An observational study of Mycosis Fungoides and Sézary Syndrome, run by Kyowa Kirin Pharmaceutical Development Ltd at 19 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides and Sézary Syndrome
- What is being tested?
- Poteligeo
- How many people
- 73 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 9 Nov 2022to 7 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
Italy6 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona
Ancona
IRCCS A.O.U. Policlinico S. Orsola - Malpighi
Bologna
Azienda Ospedaliero- Universitaria Careggi
Florence
Ematologia Policlinico di Milano
Milan
IFO-San Gallicano IRCCS
Rome
Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli
Rome
United States5 sites
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, 22031
Colombia University Medical Center
New York, New York, 10032
Fred Hutchinson Cancer Center
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63108
United Kingdom4 sites
Clatterbridge Hospital - Wirral University Teaching Hospital Nhs Foundation Trust
Bebington
University Hospital Birmingham
Birmingham
The Christie NHS Foundation Trust
Manchester
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham
Spain2 sites
Hospital Del Mar
Barcelona
Hospital Universitari de Bellvitge
Barcelona
United Arab Emirates1 site
Sheikh Shakhbout Medical City
Abu Dhabi, Abu Dhabi Emirate, 11001
About this study
Official title: 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.
Read the 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.
- Conditions
- Mycosis Fungoides and Sézary Syndrome
- Being tested
- Poteligeo
- Medical subject headings
- Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoteligeoDrug
Also called Mogamulizumab
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MF/SS | Adult patients with diagnosed MF/SS receiving Poteligeo treatment. Receives: Drug: Poteligeo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: First dose visit, at week 12 after the first Poteligeo® administration, and within 4 weeks of treatment discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start9 Nov 2022
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis Fungoides and Sézary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyowa Kirin Medical Affairs Division, Study director, Kyowa Kirin Medical Affairs Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455931
- Sponsor's protocol ID
- 2022-05-WW-POT
- Acronym
- PROSPER
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome
- ClinicalTrials.gov ID
- NCT05455931
- Acronym / sponsor ID
- PROSPER / 2022-05-WW-POT
- Conditions
- Mycosis Fungoides and Sézary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MF/SS | – | Drug: PoteligeoAdult patients with diagnosed MF/SS receiving Poteligeo treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PoteligeoAlso: MogamulizumabPoteligeo 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. | Drug | Patients with MF/SS |
Primary outcome
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.
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
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyowa Kirin Medical Affairs Division study director
Kyowa Kirin Medical Affairs Division
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycosis Fungoides and Sézary Syndrome, run by Kyowa Kirin Pharmaceutical Development Ltd at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy, United States, United Kingdom, Spain, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.