Clinical trial · Observational
Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)
Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome
NCT05455931CI-TRIAL-00116073PROSPERcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mycosis Fungoides and Sézary Syndrome | Mycosis Fungoides and Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Poteligeo | Drug | Mogamulizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients with MF/SS
- description
- Adult patients with diagnosed MF/SS receiving Poteligeo treatment.
- interventionNames
- Drug: Poteligeo
Primary outcomes (4)
- measure
- To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo.
- timeFrame
- Weekly for first 16 weeks, then every 4 weeks until Week 48, at treatment discontinuation and 8 and 16 weeks after treatment discontinuation.
- description
- 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.
- measure
- To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo.
- timeFrame
- Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.