Trial record 1 of 1 for:
NCT05455931
Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER) (PROSPER)
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| ClinicalTrials.gov Identifier: NCT05455931 |
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Recruitment Status :
Recruiting
First Posted : July 13, 2022
Last Update Posted : February 13, 2023
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Sponsor:
Kyowa Kirin Pharmaceutical Development Ltd
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development Ltd
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Mycosis Fungoides and Sézary Syndrome | Drug: Poteligeo |
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 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. Patients will be followed for up to 50 weeks from study enrollment.
| Study Type : | Observational |
| Estimated Enrollment : | 80 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome |
| Actual Study Start Date : | November 9, 2022 |
| Estimated Primary Completion Date : | September 5, 2024 |
| Estimated Study Completion Date : | September 5, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Fungal Infections
Drug Information
available for:
Mogamulizumab
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients with MF/SS
Adult patients with diagnosed MF/SS receiving Poteligeo treatment.
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Drug: Poteligeo
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 Name: Mogamulizumab |
Primary Outcome Measures :
- 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)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-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 20 sites across North America and Europe.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05455931
Contacts
| Contact: Division Project Management Department | 609-919-1100 | kkd.clintrial.82@kyowakirin.com |
Locations
Show 19 study locations
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development Ltd
| Responsible Party: | Kyowa Kirin Pharmaceutical Development Ltd |
| ClinicalTrials.gov Identifier: | NCT05455931 |
| Other Study ID Numbers: |
2022-05-WW-POT |
| First Posted: | July 13, 2022 Key Record Dates |
| Last Update Posted: | February 13, 2023 |
| Last Verified: | February 2023 |
Additional relevant MeSH terms:
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Mycoses Mycosis Fungoides Sezary Syndrome Syndrome Disease Pathologic Processes Bacterial Infections and Mycoses Infections Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell |
Lymphoma, Non-Hodgkin Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Mogamulizumab Antineoplastic Agents |