Actively Recruiting
Phase IIB Study of Ropeginterferon Alfa-2b for Adults with Cutaneous T-Cell Lymphoma Who Have Not Responded to Prior Skin Therapies
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
38
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating Ropeginterferon-alfa 2b in patients with Cutaneous T-Cell Lymphoma CTCL who have not responded to at least two prior skin-directed treatments or have less than a complete response to phototherapy, extracorporeal photopheresis ECP, or total skin electron beam therapy TSET. This phase IIB study aims to find the recommended dose for future studies and focuses on patients with stage IA-IIIB CTCL, including specific subtypes such as Mycosis Fungoides and Se9zary Syndrome. Participants receive Ropeginterferon alfa-2b through subcutaneous injections every two weeks at escalating doses of 250, 350, or 500 b5g. Once the recommended phase II dose is identified, an additional group of 20 participants will receive treatment at this dose to further assess safety and effectiveness. No placebo or randomization is involved in this open-label trial. During the study, participants will be monitored for dose-limiting toxicities and overall response rates over up to one year. Assessments include regular clinical evaluations, laboratory tests, and adherence to the injection schedule. The study also observes participants for safety and disease progression, with a total participation duration depending on treatment response and dosing schedules.
CONDITIONS
Brief Title
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
Research Team
R
Richard Corona
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