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Clinical trial

Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome

ID
Name
2022-05-WW-POT
Description
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 arms
Trial start
2022-11-09
Estimated PCD
2024-09-05
Trial end
2024-09-05
Status
Recruiting
Treatment
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.
Arms:
Patients with MF/SS
Other names:
Mogamulizumab
Size
80
Primary endpoint
To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo.
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.
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.
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
First dose visit, at week 12 after the first Poteligeo® administration, and within 4 weeks of treatment discontinuation.
Eligibility criteria
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 in the study in a manner approved by Institutional Review Board(IRB)/ Independent Ethics Committee (IEC) and local regulations Exclusion Criteria: 1. Patient unable to participate in all aspects of the study and/or does not agree to the collection of data from medical records 2. Patient currently participating in an interventional clinical trial
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-02-13

1 organization

1 product

1 indication

Organization
Kyowa Kirin Pharmaceutical Development
Product
Poteligeo
Indication
Mycosis Fungoides and Sézary Syndrome