A Phase I/IB Study of Ropeginterferon in Patients With Cutaneous T-Cell Lymphoma (CTCL)
H. Lee Moffitt Cancer Center and Research Institute
Summary
This is a single-center, phase I/IB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed at least two prior lines of skin-directed therapy (Stage IA-IB) or have less than a complete response to phototherapy or extracorporeal photopheresis (ECP) or total skin electron beam therapy (TSET), or stable/progressive disease after at least two lines of topical therapy (Stage IIA-IIIB).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosed with cutaneous T-cell lymphoma, stage IA-IIIB CTCL according to WHO-EORTC classification, specifically the following subtypes: Mycosis Fungoides (MF); Sézary Syndrome (SS); Lymphomatoid Papulosis (LyP) or other rare CTCL variants per WHO-EORTC classification, provided the investigator determines the disease course warrants systemic treatment. * A) For Stage IA-IB: Must have failed at least two prior lines of skin-directed therapy, where "failed" is defined as any of the following: a. Inadequate response (persistent clinically significant lesions or symptoms), b…
Interventions
- DrugRopeginterferon alfa-2b
Will be administered via subcutaneous injection once every 2 weeks
Location
- Moffitt Cancer CenterTampa, Florida